Filterflow® 352424Recalls & reported problems
B. Braun Medical Inc. · Primary Gravity Filtered Set with Non-Needle-free Injection Site · Class 2
All models of Filterflow (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046963402273), received between Nov 16, 2018 and Nov 23, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (3 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.
Most reported problems
Device problems
- Air/Gas in Device3
- Improper Flow or Infusion3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 23, 2022Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY. EVENT 1: CUSTOMER REPORTS AIR IN LINE DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15854262 ↗MalfunctionNov 23, 2022Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 3: CUSTOMER REPORTS AIR IN LINE DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15854191 ↗MalfunctionNov 23, 2022Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER REPORTS AIR IN LINE DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15854187 ↗MalfunctionNov 16, 2018Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED BY THE USER FACILITY: THE LINE DETACHED ABOVE THE FILTER WHICH ALLOWED AIR INTO THE LINE CAUSING A STEADY STREAM OF BUBBLES TO COME INTO THE DRIP CHAMBER, INHIBITING THE LINE TO DRIP PROPERLY. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8078427 ↗MalfunctionNov 16, 2018Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED BY THE USER FACILITY: THE LINE DETACHED ABOVE THE FILTER WHICH ALLOWED AIR INTO THE LINE CAUSING A STEADY STREAM OF BUBBLES TO COME INTO THE DRIP CHAMBER, INHIBITING THE LINE TO DRIP PROPERLY. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8078426 ↗MalfunctionNov 16, 2018Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED BY THE USER FACILITY: THE LINE DETACHED ABOVE THE FILTER WHICH ALLOWED AIR INTO THE LINE CAUSING A STEADY STREAM OF BUBBLES TO COME INTO THE DRIP CHAMBER, INHIBITING THE LINE TO DRIP PROPERLY. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8078423 ↗
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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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