MalfunctionFPK
MEDEX 3-WAY STOPCOCK EXTENSION SET
Received Feb 9, 2026 · Event occurred Jan 21, 2025
Report 1526863-2026-00016 · MDR key 24299514
Device
Generic name
Tubing, Fluid Delivery
Manufacturer
Icu Healthcare Manufacturing S.a. De C.v.Catalog number
MX43660
Lot number
NI
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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 INFORMATION BECOMES AVAILABLE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT THE LINE KEPT BREAKING AND RESULTED IN BLOOD LOSS. THERE WAS REPORTED PATIENT INVOLVEMENT AND THERE WAS NO REPORTED PATIENT HARM.