Filterflow® 473989Recalls & reported problems
B. Braun Medical Inc. · 0.2 Micron Filtered Extension Set with 1 Non-needle free injection site · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04045928016265), received between Jul 11, 2018 and Jun 9, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
- Improper Flow or Infusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2021Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED BY THE USER FACILITY: CUSTOMER STATES THAT SHE IS CURRENTLY USING PRODUCT 473989 TO FILTER HER TPN AND THAT THE FILTER IS LETTING AIR IN. SHE STATES THAT SHE WATCHES ENTIRE TUBING LENGTHS OF AIR BEING INFUSED INTO HER PORT "ALL NIGHT LONG". REVIEWED WITH CUSTOMER HOW TO PROPERLY FLUSH THE EXTENSION SET. CUSTOMER STATES THAT SHE IS FLUSHING IT CORRECTLY AND GETTING ALL THE AIR OUT, BUT THAT AS HER TPN IS INFUSING AIR IS GETTING IN. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11970436 ↗MalfunctionJul 11, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: DURING THE APPLICATION OF CHEMOTHERAPY, THE HEAD NURSE OBSERVED LEAKAGE OF TAXOL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7678868 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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