MEDEX 3-WAY STOPCOCK EXTENSION SET

Additional Manufacturer Narrative

H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS NO LOT NUMBER WAS RECEIVED.

Additional Manufacturer Narrative

UDI SECTION OF D4 IS UNKNOWN, NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. B3: DATE OF EVENT IS UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. D4: EXPIRATION DATE AND H4: MANUFACTURE DATE ARE UNKNOWN; NO LOT NUMBER HAS BEEN PROVIDED. H3 - OTHER: DEVICE HAS NOT BEEN RETURNED TO DATE. 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 THERE WERE 6 INSTANCES OF A LINE THAT SLIPPED AND DISCONNECTED THAT RESULTED IN PATIENTS BLEEDING. THE DEVICE IS UNKNOWN IF AVAILABLE FOR INVESTIGATION. THERE WAS PATIENT INVOLVEMENT. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR ADVERSE EVENT.