MEDEX SMALL BORE EXTENSION SET W/ THREE-WAY STOPCOCK

Additional Manufacturer Narrative

THIS COMPLAINT WAS INCORRECTLY FILED UNDER THIS REGISTRATION NUMBER, PLEASE REFERENCE MRN 1526863-2025-00033-00 FOR DETAILS PERTINENT TO THIS EVENT.

Additional Manufacturer Narrative

D4. PRIMARY UDI NUMBER: THE PRIMARY DI# HAS BEEN USED AS THE LOT/SERIAL INFORMATION IS UNKNOWN. H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS 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.

Description of Event or Problem

IT WAS REPORTED THAT THE CARDIOVASCULAR INTENSIVE CARE UNIT EXPERIENCED FOUR INSTANCES OVER A FEW DAYS WHERE THE DEVICE BROKE AT THE CONNECTION BETWEEN THE TUBING PIGTAIL AND THE 3-WAY STOPCOCK. THESE BREAKS RESULTED IN BLOOD SPILLS ON THE PATIENT, THEIR BEDS, AND THE FLOORS. THE EVENT OCCURRED ON (B)(6) 2025 AT 5 PM DURING USE ON THE PATIENT. THERE WAS MEDICATION BEING USED WITH THE PRODUCT AND THERE WAS DELAY IN THERAPY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.