MEDEX STOPCOCK EXTENSION

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.

Description of Event or Problem

IT WAS REPORTED THAT THE EXTENSION TUBING BROKE OFF AT THE STOPCOCK CONNECTION. THERE WAS PATIENT INVOLVEMENT, AND NO HARM REPORTED.

Additional Manufacturer Narrative

D9: DATE RETURNED TO MFG.: 10/9/2024. H3 AND H6. CODES: UPDATED. ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE COMPLAINT WAS CONFIRMED. THERE WAS SEPARATION OF THE SOLVENT BOND OF STOPCOCK AND TUBE. ADDITIONALLY, IT WAS OBSERVED SOLVENT SIGNATURE WAS PRESENT ON THE TUBE. THE CAUSE WAS MANUFACTURING. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER. AWARENESS WAS MADE TO OPERATION PERSONNEL WHO PERFORM THE ASSEMBLY PROCESS, AND THE ISSUE WILL BE MONITORED FOR THRESHOLD OR ESCALATION.