Filterflow® 473995Recalls & reported problems
B. Braun Medical Inc. · 1.2 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963363024), received between Apr 4, 2019 and Sep 10, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Improper Flow or Infusion” (2 reports).
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
- Improper Flow or Infusion2
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2019Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED VIA MEDWATCH NUMBER: MW5088368. EVENT 1: " RN WAS HANGING STERILE FLUIDS FOR CENTRAL LINE FLUID CHANGE WHEN THE FILTERED EXTENSION SET WAS FOUND TO BE FILL WITH AIR DESPITE BEING PRIMED WITH FLUID. RN REMOVED FILTER FROM PRIMED LINE AND REPLACED WITH A FUNCTIONAL FILTER SET PRIOR TO ATTACHING TO PATIENT." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8981258 ↗MalfunctionSep 10, 2019Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED VIA MEDWATCH NUMBER: MW5088369. EVENT 2: " RN WAS HANGING STERILE FLUIDS FOR CENTRAL LINE FLUID CHANGE AND DISCOVERED FILTER SET WOULD FILL WITH AIR DURING LINE CHANGE SET UP CONTRIBUTING TO AIR IN PRIMED LINE." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8981257 ↗MalfunctionApr 4, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED VIA MEDWAYCH NUMBER MW5084697: PATIENT'S BLOOD WAS BACKING UP IN THE UVC LINE AND FLUID TUBINGS. LIPID FILTER WAS HALF WAY EMPTY. LINE WAS FLUSHED AND FILTER WAS REPLACED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8483153 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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