MEDEX 3-WAY STOPCOCK EXTENSION SET

Additional Manufacturer Narrative

D9 - DATE RETURNED TO MANUFACTURER: 27-MAR-2024. H3 AND H6 - EVALUATION CODES: UPDATED. DEVICE EVALUATION: ONE USED SAMPLE OUTSIDE ITS ORIGINAL PACKAGE WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING FOUND THE SAMPLE DID NOT EXHIBIT LEAK CONDITION. THE COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS. AWARENESS OF THE REPORTED COMPLAINT WAS GIVEN TO PERSONNEL WHO PERFORM THE ASSEMBLY PROCESS.

Description of Event or Problem

IT WAS REPORTED THAT THE EXTENSION TUBING TO ARTERIAL LINE BROKE OFF AT PATIENT END CAUSING THE TUBING TO DISCONNECT FROM PATIENT'S ARTERIAL LINE. REGISTERED NURSE WAS PRESENT TO IMMEDIATELY APPLY PRESSURE AT ARTERIAL CATHETER SITE EVEN THOUGH THEY HAD SOME BLEEDING FROM CATHETER WITH DISCONNECTION. LOSS OF ACCESS AND PATIENT REQUIRED A NEW ARTERIAL LINE INSERTION PROCEDURE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

H3: OTHER; DEVICE NOT RETURNED TO MANUFACTURER. 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.