MEDEX SMALL BORE EXTENSION SET W/ THREE-WAY STOPCOCK

Description of Event or Problem

IT WAS REPORTED THAT AFTER APPROXIMATELY ONE HOUR OF INFUSION, THE NURSE NOTED THE 3-WAY STOP COCK TO BE CRACKED ON THE LEVOPHED SIDE. PATIENT WAS NOTED TO HAVE HEMODYNAMIC INSTABILITY WHICH REQUIRED FREQUENT TITRATION UP AND DOWN OF LEVOPHED. THERE WERE UNKNOWN PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

Additional Manufacturer Narrative

LOT NUMBER WAS NOT PROVIDED THEREFORE LOT HISTORY REVIEW CANNOT BE EXECUTED. 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

THIS COMPLAINT WAS INCORRECTLY FILED UNDER THIS REGISTRATION NUMBER, PLEASE REFERENCE MRN1526863-2025-00039-00 FOR DETAILS PERTINENT TO THIS EVENT.