MEDEX SMALL BORE EXTENSION SET W/ THREE-WAY STOPCOCK
Received Feb 7, 2025 · Event occurred Dec 1, 2024
Report 9616567-2025-00019 · MDR key 21333501
Device
Generic name
Tubing, Fluid Delivery
Manufacturer
Smiths Healthcare Manufacturing S.a. De C.v.Catalog number
MX43660
Lot number
4457071
Product problems
- Disconnection
- Disconnection
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE THREE-WAY STOPCOCKS ON THE A-LINES CAUSED MULTIPLE DISCONNECTIONS FROM THE A-LINES. THE CONNECTION WAS NOT SECURE ENOUGH AND COULD NOT BE MADE MORE SECURE LEADING TO DISCONNECTION. THE OPERATOR OF DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Additional Manufacturer Narrative
B3. DATE OF EVENT: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, BUT DAY 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.
Additional Manufacturer Narrative
THIS COMPLAINT WAS INCORRECTLY FILED UNDER THIS REGISTRATION NUMBER, PLEASE REFERENCE MRN 1526863-2025-00049-00 FOR DETAILS PERTINENT TO THIS EVENT.