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 TUBING GOT DISCONNECTED FROM THE PATIENT ARTERIAL LINE WHILE WORKING WITH THE PATIENT. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT HOSPITAL. IT DID NOT LEAD TO HARM, BUT THE ARTERIAL LINE HAD TO BE REMOVED, AND PATIENT HAD MODERATE AMOUNT OF BLEEDING NOTED FROM THE DISLODGEMENT. THERE WAS AN ONGOING MONITORING OF THE PATIENT INVOLVED.

Additional Manufacturer Narrative

D3: MFG. ESTABLISHMENT NAME UPDATED. H3: THE DEVICE WAS RECEIVED FOR EVALUATION WITH THE TUBING SEPARATED FROM THE STOPCOCK AND THE FEMALE LUER NOT RETURNED. NO MANUFACTURING ANOMALIES WERE IDENTIFIED IN THE LOT HISTORY REVIEW. VISUAL INSPECTION CONFIRMED THE SEPARATION WITH ADEQUATE ADHESIVE OBSERVED ON THE TUBING. FUNCTIONAL TESTING DEMONSTRATED THE BOND STRENGTH MET SPECIFICATION. THE COMPLAINT OF SEPARATION WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE MISSING COMPONENT.