MalfunctionFPB
MEDEX ULTRA SMALL BORE EXTENSION SETS
Received Apr 1, 2022 · Event occurred Jan 13, 2022
Report 3012307300-2022-05714 · MDR key 13977981
Device
Generic name
Filter, Infusion Line
Manufacturer
Smiths Medical Asd, Inc.Model number
MX448HFBCatalog number
MX448HFB
Lot number
4178571
Product problems
- Obstruction of Flow
- Obstruction of Flow
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED ON MEDWATCH (B)(4) IV LIPID FILTER NOT ALLOWING LIPIDS TO PASS THROUGH FROM IV TUBING INTO THE FILTER. CHANGED FILTER WITH DIFFERENT LOT NUMBER, AND STILL DID NOT WORK. NO ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
OTHER TEXT: ONE UNIT WAS RETURNED FOR INVESTIGATION. UPON PHYSICAL INSPECTION, IT WAS FOUND THAT THE COMPLAINED ISSUE COULD BE DUPLICATED. THE LEAKAGE IS RELATED TO A SUPPLIER ISSUE. A DHR REVIEW WAS DONE AND NO ISSUES RELATED TO THE ORIGINAL ISSUE WERE FOUND.