MaxGuard ME1227Recalls & reported problems
BD Switzerland Sàrl · Extension Set, (minbore) 15 cm (6 in) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403236136), received between Oct 3, 2022 and Oct 3, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Misconnection” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Misconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2022Misconnection; Misconnection
IT WAS REPORTED WHILE USING BD 6 IN NON-DEHP MINIBORE EXTENSION SET THE LOOSE CONNECTION LED TO LEAKS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RISK MANAGEMENT STAFF RECEIVED THREE REPORTS FROM THE CT TECHNICIANS THAT THE NEW IV EXTENSION SETS, BD MAXGAURD EXTENSION SET WERE NOT TIGHT ENOUGH AND CONTRAST WAS BLOWING OUT IV LINES AND BLOWING OUT OF THE CLAVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15534483 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.