MaxZero MZ9326Recalls & reported problems
BD Switzerland Sàrl · Minibore tri-fuse extension set, IV connector 18 cm (7 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 10885403427251), received between May 1, 2023 and May 23, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Component Missing1
- Material Split, Cut or Torn1
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.
MalfunctionMay 23, 2023Break; Break
IT WAS REPORTED WHILE USING BD MAXZERO¿ EXTENSION SET, MINIBORE, TRIFUSE THE PRODUCT WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MZ9326 LOT# 22119144 VERBATIM:DESCRIBE THE EVENT OR PROBLEM: BD MAX ZERO TRIFUSE WITH MISSING LUER LOCK CONNECTOR ON THIRD END AND LINE APPEARING AS THOUGH IT WAS CUT, PACKAGE INTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16987763 ↗MalfunctionMay 1, 2023Component Missing; Material Split, Cut or Torn
BD MAX ZERO TRIFUSE WITH MISSING LUER LOCK CONNECTOR ON THIRD END AND LINE APPEARING AS THOUGH IT WAS CUT, PACKAGE INTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16843414 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page