SOL-M

Additional Manufacturer Narrative

DESPITE MULTIPLE FOLLOW-UPS, THE LOT/BATCH NUMBER COULD NOT BE OBTAINED FROM THE CUSTOMER. CONSEQUENTLY, BATCH RECORD REVIEW AND ARCHIVED SAMPLE ANALYSIS COULD NOT BE PERFORMED. SOL MILLENNIUM RECEIVED THE RETURNED SUBJECT DEVICE FOR EVALUATION. DUE TO CONTAMINATION WITH CYTOSTATIC DRUG RESIDUE, ONLY VISUAL INSPECTION COULD BE PERFORMED. VISUAL INSPECTION CONFIRMED THAT THE ELASTOMERIC STOPPER WAS PARTIALLY DETACHED FROM THE PLUNGER ASSEMBLY. THE RETURNED DEVICE WAS RECEIVED WITH A CLOSED SYSTEM TRANSFER DEVICE (CSTD) ATTACHED. THEREFORE, THE POTENTIAL INFLUENCE OF THE ASSEMBLED SYSTEM, INCLUDING INTERACTION BETWEEN THE SYRINGE AND THE CSTD, CANNOT BE EXCLUDED. AS NO FUNCTIONAL TESTING COULD BE PERFORMED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. SOL MILLENNIUM WILL CONTINUE TO MONITOR COMPLAINT TRENDS THROUGH ITS POST-MARKET SURVEILLANCE PROCESS.

Description of Event or Problem

CUSTOMER REPORTED THE SYRINGES IN QUESTION, WHICH WERE CONTAMINATED WITH CYTOSTATIC DRUGS. THE FOLLOWING TWO ISSUES HAVE OCCURRED: 1. LIQUID BEHIND THE BLACK STAMP. 2. THE STAMP HAS COME LOOSE FROM THE PLUNGER. IT IS ALSO POSSIBLE THAT THE SCREW-ON ADAPTER FROM SIMPLIVA CAUSED THIS PROBLEM, AS IT MAY NOT HAVE OPENED PROPERLY.