MaxGuard MFS124Recalls & reported problems
BD Switzerland Sàrl · 15 Drop Flow Controller Administration Set, with 2 Needless Y-Sites and Check Valve, 191 cm (75 in) · Class 2
Data updated Oct 13, 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 10885403236396), received between Sep 12, 2019 and Sep 19, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
Patient problems
- No Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS SIGNIFICANT LEAKING UPON INSERTION OF ANY MEDICATION/FLUID USING A 3ML SYRINGE TO THE UPPER NEEDLELESS PORT.
Patient problems: No Information
MAUDE report 9087835 ↗MalfunctionSep 12, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A LEAK TO THE UPPER NEEDLELESS CONNECTOR OF THE IV TUBING UPON INJECTION OF ANY MEDICATION OR FLUID USING A 3ML SYRINGE.
Patient problems: No Information
MAUDE report 9010490 ↗
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- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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