Disc Filter 415002Recalls & reported problems
B. Braun Medical Inc. · 0.2 Micron SUPOR® Aspiration / Injection Disc Filter · Class 2
Data updated Oct 16, 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 04022495769770), received between Apr 13, 2020 and Sep 22, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): WHEN CIRCLE PRIMING ETOPOSIDE USING THE LOW ADSORPTION SET (REF (B)(4)), LOT 0061870727, THE HIGH VOLUME PUMP GAVE ERROR " HIGH DOWNSTREAM PRESSURE". A FILTER (0.2UM) (PRODUCT CODE PF2000, LOT GR00013070) WAS ATTACHED TO THE END OF THE LINE, ATTACHED TO THE PHASEAL, ATTACHED TO THE BAG (FOR CIRCLE PRIMING). ALL CONNECTIONS WERE CHECKED, AND RECONNECTED, TO ENSURE THAT THE CONNECTIONS WEREN'T CONTRIBUTING TO THE HIGH PRESSURE ERROR. DUE TO UNSUCCESSFUL ATTEMPT TO WORK THROUGH THE ERROR AND FINISH PRIMING THE LINE SUCCESSFULLY, THE LINE WAS TRANSFERRED TO A DIFFERENT HIGH VOLUME PUMP. THIS ALLOWED FOR SUCCESSFUL PRIMING, HOWEVER A NEW ERROR STARTED TO OCCUR; THE PUMP INDICATED "AIR BUBBLE" WAS CONTRIBUTING TO THE STOP ERROR. AFTER SEVERAL ATTEMPTS TO CLEAR THE AIR BUBBLE, THE ERROR WAS PERSISTENT, SO THE LINE WAS TRANSFERRED BACK TO THE ORIGINAL HIGH VOLUME PUMP, WHICH THEN CONTINUED TO GIVE THE "AIR BUBBLE" ERROR. A THIRD HIGH VOLUME PUMP WAS USED, WHICH ALSO INDICATED THE "AIR BUBBLE" STOP ERROR. WE THEN DECIDED TO CHANGE THE LOW ADSORPTION SET (THE LINE). WE DID THIS BY UNSPIKING THE ETOPOSIDE AND INSTEAD, IN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17804135 ↗MalfunctionApr 13, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: BLACK PARTICLES WERE FOUND INSIDE THE 0.2 MCG DISK FILTER.
Patient problems: No Patient Involvement
MAUDE report 9954636 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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