Letter to Stakeholders: Communication on certain needleless pre-filled glass syringes

November 17, 2010

Dear Colleague,

The U.S. Food and Drug Administration (FDA) is seeking your help in communicating an important safety message about pre-filled needleless glass syringes to people affiliated with your organization. We hope you will share this information to ensure they are aware of this issue and can take steps to remedy the problem.

The FDA has received reports of compatibility problems when certain needleless pre-filled glass syringes are used with some needleless intravenous (IV) access systems. These syringes may malfunction, break, or become clogged during the process of attempting to connect to needleless IV access systems. In some cases, the syringe may damage the IV tubing and/or the needleless connector and require reestablishment of intravenous access. These failures can cause a delay in administration of the medication. While FDA is concerned about this incompatibility, we are most concerned with situations in which a delay in delivery of the drug could potentially result in serious harm to patients.

Most of the reports FDA has received have been related to pre-filled needleless glass syringes that contain adenosine. Adenosine is a cardiac drug that is administered when a patient has a rapid or irregular heart rhythm in an attempt to return their heart rhythm to normal. Adenosine must be injected rapidly into the blood stream in emergency situations and this failure could delay treatment. Adenosine pre-filled glass syringes are marketed by Teva, Sagent, Baxter, and Wockhardt. Adenocard, an adenosine product manufactured by Astellas, is not packaged in pre-filled glass syringes and is therefore not affected by this issue.

The FDA has also received reports of problems related to certain pre-filled needleless glass syringes containing the cardiac drug amiodarone.

To mitigate potential risks to patients, FDA recommends that healthcare professionals evaluate their medication stock and consider stocking adenosine supplied in vials or pre-filled plastic syringes as a back up measure. Healthcare professionals, risk managers, and staff who purchase, stock, or administer emergency crash cart medications, operating room medications, emergency drug boxes, or types of emergency drug caches should be alerted to this compatibility problem. [National Drug Code (NDC) numbers for affected adenosine and amiodarone products are listed in the attached appendix]

FDA has expanded the scope of its review to include all currently marketed pre-filled needleless glass syringes intended for use with needleless intravenous access systems, where delay in administration could potentially result in a life threatening event. FDA is working with manufacturers to correct the problem and identify additional mitigation strategies and is continuing to review the issue to determine the appropriate regulatory action(s).

The agency asks that healthcare professionals and risk managers report any adverse events or problems experienced with the use of needleless pre-filled glass syringes to FDA's MedWatch program at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.

The FDA will update the clinical community as new information of public health importance becomes available. Thank you for your help in communicating this important safety message.

Sincerely,

The U.S. Food and Drug Administration

APPENDIX.