NRFIT ADMINISTRATION SET
Received Mar 19, 2025 · Event occurred Feb 13, 2025
Report 9617604-2025-00198 · MDR key 21646900
Device
Generic name
Administrations Sets With Neuraxial Connectors
Manufacturer
Smiths Healthcare Manufacturing S.a. De C.v.Model number
21-7624-24Catalog number
21-7624-24
Lot number
6006521
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS COMPLAINT WAS INCORRECTLY FILED UNDER THIS REGISTRATION NUMBER, PLEASE REFERENCE MRN 3012307300-2025-05673 FOR DETAILS PERTINENT TO THIS EVENT.
Description of Event or Problem
IT WAS REPORTED THAT THE TUBING AT THE CLIP-ON LEAKED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.
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.