MaxGuard ME1048Recalls & reported problems
BD Switzerland Sàrl · Extension Set, (minibore) 30.5 cm (12 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403236006), received between Jul 29, 2020 and Nov 23, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Backflow” (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
- Backflow1
- Leak/Splash1
- Material Separation1
Patient problems
- Low Blood Pressure/ Hypotension1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 23, 2022Material Separation; Material Separation
IT WAS REPORTED THAT THE BD 12 IN NON-DEHP MINIBORE EXTENSION SET CLOSE FELL INTO 3 PIECES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN DECIDED TO MOVE VASOPRESSIN LINE CLOSER TO THE PATIENT IN THE GTT LINE BUT WHEN SHE WENT TO UNSCREW THE MEDICATION TUBING IT FELL INTO 3 PIECES.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 15852739 ↗MalfunctionJul 29, 2020Backflow; Leak/Splash; Backflow; Leak/Splash
IT WAS REPORTED THAT THE 12 IN NON-DEHP MINIBORE EXTENSION SET EXPERIENCED LEAKAGE AND COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PIV WAS PLACED USING THE BD MAXGUARD EXTENSION SET. LESS THAN 30 MINUTES LATER PATIENT NOTIFIED NURSE THAT IT WAS "LEAKING". UPON EVALUATION IS WAS NOTED THAT BLOOD WAS LEAKING FROM THE CONNECTION SITE OF THE EXTENSION SET AND IV HUB. IT SEEMS THE EXTENSION SET BECAME LOOSE FROM THE HUB, ALTHOUGH SCREWED ON TIGHTLY AND TAPED DOWN. EXTENSION SET WAS CHANGED OUT WITH A DIFFERENT BRAND.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10342078 ↗
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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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