Filterflow® 473994Recalls & reported problems
B. Braun Medical Inc. · 1.2 Micron Filtered Extension Set · Class 2
All models of Filterflow (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04046963789695), received between Feb 16, 2018 and Sep 11, 2025 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device4
- Inadequate Filtration Process3
- Improper Flow or Infusion1
- Infusion or Flow Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2025Leak/Splash; Air/Gas in Device; Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE DEVICE LEAKED EVEN WHEN CLAMPED IN MULTIPLE PLACES. AFTER BEING ATTACHED TO PATIENT, BLOOD AND AIR WERE PULLED INTO LINE BEFORE FILTER. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23026353 ↗MalfunctionSep 11, 2025Inadequate Filtration Process; Inadequate Filtration Process
AS REPORTED BY THE USER FACILITY: AIR IS GETTING IN THE SYSTEM DURING PRIMING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23025890 ↗MalfunctionJul 25, 2025Inadequate Filtration Process; Inadequate Filtration Process
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: SET NOT WORKING PROPERLY. DETAILED INQUIRY DESCRIPTION: (B)(6) LOCATION WAS DOING A TRIAL ON THIS FILTERED EXTENSION. THEY WERE ONLY USING IT TO FILTER OUT BUBBLES IN THE LIPIDS THEY WERE GIVEN THEIR PATIENTS. THE PRODUCT DID NOT WORK PROPERLY. IT DID NOT ELIMINATE ALL THE BUBBLES. THE TARGETED POPULATION IS VERY SMALL, AND A BUBBLE CAN CAUSE HARM. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22612215 ↗MalfunctionDec 30, 2024Inadequate Filtration Process; Inadequate Filtration Process
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: THE INLINE 1.2-MICRON IV FILTERS FOR USE WITH A IV FLUID. AFTER USING THE FILTERS, WE NOTICED THAT DESPITE IT BEING A 1.2 U FILTER, THERE WERE PARTICLES OVER 10 U AFTER FILTRATION. THEY DID A PARTICLE ASSESSMENT AND THE FOUND 10-MICRON PARTICLES IN FLUID AFTER FILTRATION DESPITE USING A 1.2 MICRON FILTER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21036062 ↗MalfunctionOct 11, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED, WE HAVE HAD COMPLAINTS FROM OUR MD'S & RN'S ABOUT THE FILTER EXT SET #473994. THIS IS INTENDED TO KEEP AIR OUT OF THE IV IN FOR INFANTS; IT IS NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20428815 ↗MalfunctionFeb 1, 2023Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: CUSTOMER REPORTS AIR BUBBLES ARE FORMING IN THE FILTER WHEN RUNNING AT LOW RATE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16277489 ↗MalfunctionJan 6, 2023Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: CUSTOMER STATES FILTER 473994 FILLED WITH AIR. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16115656 ↗MalfunctionApr 23, 2019Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED BY THE USER FACILITY: THE FILTER WAS PRIMED PRIOR TO INITIATING MEDICATION TO ENSURE ALL AIR WAS REMOVED, BUT AN AIR BUBBLE BYPASSED THE FILTER AND WAS TRAVELING TOWARD THE PATIENT. THIS WAS NOTICED DURING USE. NO INJURIES WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8539990 ↗MalfunctionFeb 16, 2018Infusion or Flow Problem; Infusion or Flow Problem
AS REPORTED BY USER FACILITY: THE FILTER FILLED WITH AIR DURING THE MIDDLE OF A FAT EMULSION INFUSION SET TO A RATE OF 0.1 - 2 ML/HR. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7276310 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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