Early Alert: Convenience Kit Issue from AVID Medical
The adaptor on Namic RA syringes included in AVID Medical convenience kits may unwind during use. This mechanical failure can result in loose connections or complete disconnections during clinical procedures.
Affected parties include AVID Medical, healthcare providers using these specific convenience kits, and clinical departments performing procedures requiring Namic RA syringes.
The mechanical failure of a syringe adaptor poses significant clinical risks, including infection, blood loss, and air embolism. From a regulatory perspective, this suggests a potential need for a formal recall or Field Safety Corrective Action. Quality systems may need to investigate the root cause of the component failure within the assembly process of the convenience kits or the original syringe manufacturing.
Regulatory and QA teams should immediately identify and sequester affected convenience kits containing Namic RA syringes. Facilities should evaluate internal protocols for syringe connection integrity and update risk assessments to account for potential mechanical failure of the adaptor. Clinical staff should be alerted to the risk of unintentional disconnection during use.
The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.
Open in openFDA / FDA.gov