MEDEX SMALL BODY 3-WAY STOPCOCK

Description of Event or Problem

IT WAS REPORTED THAT THE PARTS WERE FOUND TO HAVE SILICONE POOLED INSIDE THE MALE LUER CONNECTION PORT. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

G1 MANUFACTURER ADDRESS: CORRECTED RECEIVED ONE DEVICE, UPON INSPECTION, A SMALL AMOUNT OF LIQUID WAS OBSERVED WITHIN THE MALE LUER CONNECTION PORTION OF THE STOPCOCK. THIS LIQUID WAS IDENTIFIED AS SILICONE, WHICH IS INTENTIONALLY APPLIED DURING THE ASSEMBLY PROCESS TO FACILITATE SMOOTH ROTATION OF THE STOPCOCK COMPONENTS. THE SILICONE USED IN THIS PROCESS IS MEDICAL-GRADE AND BIOCOMPATIBLE, MEANING IT IS SAFE FOR CONTACT WITH BODILY TISSUES AND FLUIDS. WHILE SILICONE IS NOT INTENDED TO ENTER THE FLUID PATH, ITS PRESENCE IN SMALL AMOUNTS DOES NOT POSE A SAFETY RISK DUE TO ITS BIOCOMPATIBILITY. AS PART OF THE INVESTIGATION, ALL RETURNED SAMPLES UNDERWENT THIS INSPECTION AND SUCCESSFULLY PASSED, CONFIRMING THAT THE AMOUNT OF SILICONE PRESENT WAS WITHIN ACCEPTABLE LIMITS AND DID NOT POSE ANY RISK TO PRODUCT FUNCTION OR PATIENT SAFETY. THIS COMPLAINT COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.