Becton-Dickinson - Disposable Syringes and Reduced Drug Potency Issues

Starting date:

September 23, 2015

Posting date:

September 23, 2015

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals, General Public

Identification number:

RA-55044

• Issue
• Who is affected
• Report health or safety concerns
• Images

Audience

Healthcare professionals working in hospitals, homecare settings and compounding facilities that use BD disposable syringes.

Key messages

• Certain lots of Becton-Dickinson (BD) general purpose disposable syringes with a specific type of stopper have been found to reduce the potency of some compounded or repackaged drugs stored in them. Healthcare professionals should consult the BD Web site to determine if syringes in their use are affected.
• BD general purpose disposable syringes are intended for fluid aspiration and prompt administration of fluids and NOT for drug storage.
• Compounded or repackaged drugs that have been stored in the affected lots of syringes should NOT be administered unless there is no suitable alternative available.
• When these syringes are used as intended, there is no known concern with regards to reduced potency.

       

Issue

Drug potency of some medications may be reduced as a result of storage in BD disposable syringes. BD has determined that the decreased potency is due to an interaction of some drugs with one of the two types of rubber stoppers in these syringes. This reduction in drug potency can result in a decrease in drug effectiveness.

To date, decreased potency has been reported to BD for the following drugs: fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, HYDROmorphone, cisatracurium, and remifentanyl. Since these drugs are used in pain management and as a component of an anesthetic regimen, a decrease in drug potency can potentially result in loss of pain control.

At this time, Health Canada does not know whether other drugs stored in syringes made by other manufacturers with similar rubber stoppers may be affected. There have been no reports of serious injury. To date, no Canadian cases related to drug potency issues have been confirmed.

Products affected

BD sterile plastic disposable syringes: BD utilizes a primary and an alternate rubber stopper supplier for these syringes. Reported complaints of drug potency loss were confirmed by BD to be with syringes using the alternate stopper.

Affected lots include: 3 mL, 5 mL, 10 mL and 30 mL BD syringes, and BD oral/enteral syringes. Consult the BD Web site to determine if syringes in your use are affected.

Please note that BD Insulin Syringes, BD PosiFlush™ Pre-filled Saline and Heparin Syringes, and BD Pharmaceutical Systems’ prefillable syringes do not use the rubber stopper associated with this issue.

Background information

BD general purpose disposable syringes are intended for fluid aspiration and prompt administration of fluids only. BD disposable syringes are NOT intended for drug storage.

To date, BD received several reports from customers in the US (all of whom prefill syringes with drugs) related to loss of drug potency when some drug products were stored for periods of time (exact timeframes unknown) in BD 3 mL and 5 mL syringes that had the alternate stopper.

BD has conducted initial testing for drug potency with fentanyl. A 10 % reduction in potency was noted within 12 hrs of filling a 5 mL syringe with 2 mL of fentanyl at a concentration of 5 µg/mL when stored in a syringe with the alternate stopper. When syringes are filled and used promptly, there is no evidence of decreased drug potency with the primary and alternate stoppers. BD is conducting additional testing with other drugs to further characterize the issue.

Who is affected

Information for consumers

Patients who have medications stored in BD general purpose syringes in their home should consult with the pharmacy or medical clinic where the prefilled syringes were obtained before administering these products. BD syringes can be identified by the BD logo displayed on the syringe itself (see image below).

Please note that BD Insulin Syringes, BD PosiFlush™ Pre-filled Saline and Heparin Syringes, and BD Pharmaceutical Systems’ prefillable syringes do not use the rubber stopper associated with this issue. 
 
You should speak to your healthcare professional if you have any questions or concerns.

Information for health care professionals

Healthcare professionals should confirm that BD syringes used for compounding or repackaging drugs do not contain the alternate stopper associated with this issue by doing the following:

• Determine if the lot number (7-digit number) of your syringes is among the affected lots. This can be done by going to the BD Web site. If the lot number appears in the file, the syringe contains the alternate stopper that is associated with decreased drug potency on storage.
• Compounded or repackaged drugs that have been stored in the affected lots of syringes should not be administered unless there is no suitable alternative available.
• Contact BD Customer Service at 1-866-979-9408 or send an email to Syringe_Inquiry_Canada@bd.com for further information.

BD general purpose disposable syringes should only be used for fill and immediate use.

If your institution or pharmacy has distributed this product further, notify all healthcare professionals who may have received compounded or repackaged product that has been stored in the affected lots of syringes.

Action taken by Health Canada

BD, in consultation with Heath Canada, communicated to customers in Canada on August 31, 2015 (www.bd.com/ca). Further to this action, Health Canada requested more information from BD on this issue. Health Canada is continuing to monitor the situation and will communicate as required.

Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of decreased drug effectiveness or other serious or unexpected side effects in patients using BD general purpose syringes prefilled with medication should be reported to Health Canada.

Health Products and Food Branch Inspectorate
E-mail: MDCU_UCIM@hc-sc.gc.ca
Telephone: 1-800-263-9675
Fax: 1-613-960-7123

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca
Tel: 613-954-6522     
Fax: 613-952-7738

Images

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