MalfunctionFPB
MICRO-VOLUME EXTENSION SET
Received Jun 24, 2026
Report 1416980-2026-02122 · MDR key 25609868
Device
Generic name
Filter, Infusion Line
Manufacturer
Baxter Healthcare CorporationModel number
2N3342Catalog number
2N3342
Lot number
NI
Product problems
- No Flow
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP THREE LEAD CATHETER EXTENSION SETS EXHIBITED NO FLOW "PAST THE FILTER". THE EVENTS WERE IDENTIFIED IN THE NEONATAL INTENSIVE CARE UNIT (NICU) DURING TUBING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
D4 UDI: AS THE LOT # IS UNKNOWN, THE UDI WILL CONSIST OF THE PRIMARY DI NUMBER ONLY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.