MEDEX 4-WAY STOPCOCK EXTENSION SET

Additional Manufacturer Narrative

NEITHER SAMPLES NOR PICTURES WERE RECEIVED FOR THE ANALYSIS OF THIS COMPLAINT. THE REPORTED ISSUE COULD NOT BE CONFIRMED BY INVESTIGATION AS NO SAMPLES NOR PICTURES WERE PROVIDED BY THE CUSTOMER. WITHOUT THE RETURN OF THE USED SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. A DEVICE HISTORY REVIEW WAS PERFORMED, AND NO DISCREPANCIES OR ANOMALIES WERE OBSERVED DURING THE MANUFACTURING OF THIS LOT.

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 EXTENSION TUBING WAS ATTACHED TO A NEEDLELESS CONNECTOR ON ONE END AND TO A MANIFOLD WITH TWO ONGOING MEDICATIONS, HEPARIN AND PRECEDEX, ON THE OTHER END. THE NURSE TURNED THE PATIENT AND SAW THAT THE EXTENSION TUBING, CONNECTED TO THE STOPCOCK, HAD DISCONNECTED OR "POPPED OFF." A LARGE PUDDLE OF LIQUID WAS FOUND ON THE PATIENT'S BED, AND IT IS UNCLEAR HOW LONG THE PATIENT HAD BEEN WITHOUT MEDICATION. THERE WAS NO MEDICAL INTERVENTION AND PATIENT HARM.

Additional Manufacturer Narrative

D9: DATE RETURNED TO MFG.: 6/24/2025 H3 AND H6. CODES: UPDATED. UPDATED DEVICE EVALUATION: ONE USED SAMPLE OF THE SUSPECTED DEVICE/PRODUCT WAS RECEIVED. FUNCTIONAL TESTING COULD NOT BE PERFORMED AS THE TUBING DETACHED FROM COMPONENT STOPCOCK WHEN PREPARING FOR LEAK TESTING. A VISUAL INSPECTION SHOWS REMAINS OF SOLVENT ALL AROUND ITS OUTER SURFACE, EVIDENCE OF THE BONDING OF COMPONENTS. THE COMPLAINT WAS CONFIRMED HOWEVER, A PROBABLE CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER.