MEDEX 4-WAY STOPCOCK EXTENSION SET
Received Mar 6, 2025 · Event occurred Jan 1, 2025
Report 9616567-2025-00036 · MDR key 21536808
Device
Generic name
Tubing, Fluid Delivery
Manufacturer
Smiths Healthcare Manufacturing S.a. De C.v.Catalog number
MX43860
Lot number
6059665
Product problems
- Disconnection
- Disconnection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THEY HAD MULTIPLE INSTANCES OF THE EXTENSION WITH STOPCOCK GETTING DISCONNECTED AT THE CONNECTION WHERE THE STOPCOCK FUSED WITH THE EXTENSION PIECE. THERE WERE UNKNOWN PATIENT HARMS OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.
Additional Manufacturer Narrative
DATE OF EVENT WAS UNKNOWN. NO PRODUCT WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.