MEDEX EXTENSION FILTER SETS
Received Apr 11, 2025 · Event occurred Dec 1, 2024
Report 1526863-2025-00037 · MDR key 21825933
Device
Generic name
Filter, Infusion Line
Manufacturer
Smiths Healthcare Manufacturing S.a. De C.v.Catalog number
MX448HFB
Lot number
UNKNOWN
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 FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 9616567-2025-00035. THE DATE OF THAT SUBMISSION WAS 03/04/2025. B3: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED; DAY IS UNKNOWN. NO PRODUCT OR PHOTOS WERE RETURNED THEREFORE NO DEVICE ANALYSIS COULD BE COMPLETED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE SEEMED TO BE LEAKING OUT OF THE Y-SITE. ADDITIONAL FLUID WAS ORDERED FOR THE PATIENT.