MEDEX 4-WAY STOPCOCK EXTENSION SET

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 INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE PLASTIC TUBING THAT GOES INTO THE STOPCOCK EASILY COMES OFF. REPORTER STATED THAT THERE WERE INSTANCES THAT THEY HAD CHANGED OUT 3 DEVICES AND SOME INSTANCES WHEN THEY THREW THE J-LOOP AWAY. THERE WAS PATIENT INVOLVEMENT BUT IT'S UNKNOWN IF PATIENT WAS INJURED/HARMED.

Additional Manufacturer Narrative

A PICTURE OF THE SUSPECT DEVICE WAS PROVIDED FOR EVALUATION, AND A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED. NO DISCREPANCIES OR ANOMALIES WERE OBSERVED DURING THE MANUFACTURING OF THIS LOT. THE REPORTED MALFUNCTION WAS CONFIRMED THROUGH THE ANALYSIS OF THE PICTURE PROVIDED, THOUGH A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE SUSPECT DEVICE IS RETURNED OR FURTHER INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.