NON-DEHP EXT SET 1.2 MICRON FILTER
Received Feb 18, 2025 · Event occurred Jan 23, 2025
Report 9616567-2025-00031 · MDR key 21393840
Device
Generic name
Filter, Infusion Line
Manufacturer
Smiths Healthcare Manufacturing S.a. De C.v.Catalog number
MX448HFB
Lot number
6020860
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
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 LIPIDS STARTED LEAKING WHERE THE REGULAR IV TUBING MEETS THE LIPID FILTER ON A PCVC LINE. THERE WERE UNKNOWN PATIENT HARMS OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.
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 REPORTABLE INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
THIS COMPLAINT WAS INCORRECTLY FILED UNDER THIS REGISTRATION NUMBER, PLEASE REFERENCE MRN FOR DETAILS PERTINENT TO THIS EVENT.