Filterflow® 352205Recalls & reported problems
B. Braun Medical Inc. · 0.2 Micron low volume Filtered Extension Set with 1 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 04046964181245), received between Apr 4, 2019 and Sep 18, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (5 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
- Leak/Splash5
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: END USER REPORTS LEAKING DURING CHEMO USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17770397 ↗MalfunctionSep 14, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION CHEMO SPILL. CONNECTION LEAKED DOESN'T STAY ON PER RN. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17743928 ↗MalfunctionAug 25, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION - CHEMO SPILL. DETAILED INQUIRY DESCRIPTION: RN THINK IT WAS LEAKING FROM THE GREEN CONNECTION BUT COULD HAVE BEEN FROM THE CONNECTION ABOVE IT (FURTHER FROM THE PATIENT). RN CHECKED ALL CONNECTIONS BEFORE INFUSION, BUT IT STILL LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17624576 ↗MalfunctionAug 24, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CHEMO SPILL. DETAILED INQUIRY DESCRIPTION: RN THINK IT WAS LEAKING FROM THE GREEN CONNECTION BUT COULD HAVE BEEN FROM THE CONNECTION ABOVE IT (FURTHER FROM THE PATIENT). RN CHECKED ALL CONNECTIONS BEFORE INFUSION, BUT IT STILL LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17620712 ↗MalfunctionJul 10, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION - TUBING LEAKED WITH CHEMOTHERAPY WHEN CONNECTING 490037 WITH 352205. FOR REF: 352205 (FILTER EXTENSION SET) LOT #: 0061806013 WAS USED FOR THE COMPOUNDING FOR BOTH FIRST (FAULTY) AND SECOND BAG. FOR REF: 490037 (LOW ABSORPTION SET) LOT #: 00VL792441 WAS ALSO USED FOR COMPOUNDING FOR BOTH FIRST (FAULTY) AND SECOND BAG. WE COMPLETELY DISCARDED THE FIRST BAG WITH FAULTY TUBING. I HAVE MADE A BRAND NEW BAG WITH NEW TUBING ATTACHED. FOR THE SECOND BAG I RAN 40CC OF NS THROUGH THE ENTIRE TUBING AND FILTER EXTENSION SET TO EXAMINE ANY FAULTY PARTS, NONE WAS FOUND. NO INJURY REPORTED. PLEASE NOTE, ITEM 490037 WILL BE REPORTED VIA REPORT 2523676-2022-00353.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14973943 ↗MalfunctionApr 4, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE INLINE FILTER APPEARS TO HAVE A DRY ROTTED OR CONTAMINATED INJECTION SITE. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8484481 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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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