MEDEX 4-WAY STOPCOCK EXTENSION SET

Additional Manufacturer Narrative

NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

Additional Manufacturer Narrative

B3: DATE OF EVENT IS UNKNOWN; INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILLED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THEY ARE CONTINUING TO HAVE ISSUES WITH ARTERIAL LINE EXTENSION TUBING DISCONNECTIONS. THEY WERE EASILY ABLE TO DISCONNECT THE TWO PIECES, AND THEY ARE USED ON PRESSURIZED ARTERIAL LINES WHERE PATIENTS CAN LOSE LARGE VOLUMES OF BLOOD IF NOT CAUGHT IN TIME. THERE IS PATIENT INVOLVEMENT AS IT WAS USED ON PATIENTS WITH PRESSURIZED ARTERIAL LINES. THERE WAS NO PATIENT HARM REPORTED.