Letter to Stakeholders: Update on certain needleless pre-filled glass syringes
March 26, 2013
The U.S. Food and Drug Administration (FDA) is providing an update on the issue of syringe connection problems when certain pre-filled glass syringes are used with some needleless luer access devices.
FDA previously issued a Letter to Stakeholders in November 2010 and a Drug Safety Communication in May 2011 to alert health care professionals about syringe connection problems when pre-filled glass syringes are used with certain needleless luer access devices.
FDA has approved a new generic product, diphenhydramine injection (brand name Benadryl), which is contained in pre-filled glass syringes with modifications to address some of the connectivity concerns with luer access devices.
The new modified glass syringe for the diphenhydramine product has a larger internal syringe tip and an external collar (luer collar). Data from the manufacturer, BD Rx Inc., show that the syringe achieves acceptable connections with the following needles and needleless luer access devices:
- BD Eclipse™ Needle
- Terumo SurGuard2™ Safety Needle
Non-center post needleless luer access devices:
- Alaris SMARTSITE™
- B-Braun ULTRASITE™
- BD-Q SYTE™
- Maximum MAX PLUS™
- B-Braun SAFSITE™
Center-post needleless luer access devices:
- ICU Medical CLAVE™
The potential for malfunction, breaking, or clogging can still occur when these new glass syringes are used with other center post needleless luer access devices. Health care professionals can read the latest drug label at the following link:
Health care professionals should carefully consider when it is appropriate for a patient to receive a drug product contained in a pre-filled glass syringe, due to the potential risk that it may pose to the intravenous line if a problem occurs. A loss of intravenous access can lead to the need to reestablish intravenous access. The use of pre-filled glass syringes in emergency situations should be avoided, if possible. If a center post luer is in use or if the type or brand name of the luer is uncertain, then consider using alternatives to pre-filled glass syringes such as drug products contained in vials and pre-filled plastic syringes.
FDA is continuing to work with industry to further correct other glass syringe connectivity problems and to improve the design of the glass syringe. We will update the List of New Drug Products Approved with Modified Glass Syringes as new products are approved.
This new approval will help mitigate future diphenhydramine shortages.
The agency asks that health care 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 U.S. Food and Drug Administration