MaxGuard MFS132Recalls & reported problems
BD Switzerland Sàrl · 20 Drop Flow Controller Administration Set, with 2 Needless Y-Sites, 226 cm (89 in) · Class 2
All models of MaxGuard (49)
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 10885403236419), received between Oct 1, 2021 and Nov 7, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Complete Blockage2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED BY THE CUSTOMER THAT WHEN ADMINISTERING MEDS THROUGH THE BD GRAVITY ADMINISTRATION SET IT NO LONGER DRIPPED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: MFS132, BATCH #:22099219. IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING WAS DEFECTED. VERBATIM: MDS-ISD VERBATIM: WHEN DID THIS OCCUR? IT APPEARS THAT WHEN WE WERE RESTOCKED, THIS PARTICULAR BATCH WAS DEFECTIVE. WHAT IS THE PRODUCT #? MFS132 LOT NUMBER 22099219. CAN YOU ADVISE ANY ADDITIONAL DETAILS THAT OCCURRED? AFTER ADMINISTERING MEDS THROUGH THE Y-SITES THE TUBING NO LONGER DRIPS, RESULTING IN US HAVING TO CHANGE OUT THE ENTIRE SET. WERE THERE ANY ADVERSE EVENTS? NO, EACH TIME THE ACTUAL IV WAS PATENT WITH BLOOD RETURN. IS THE TUBING AVAILABLE FOR RETURN OR DO YOU HAVE A PHOTO? WE DISCARDED THE DEFECTIVE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15749262 ↗MalfunctionOct 1, 2021Complete Blockage; Complete Blockage
IT WAS REPORTED MAXGUARD FLOW CONTROLLER ADMINISTRATION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTROLLER FOR FLOW WAS LOCKED OPEN. COULD NOT ADJUST".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12562642 ↗
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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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