MaxZero MZ5308Recalls & reported problems
BD Switzerland Sàrl · BI-FUSE PRESSURE RATED 2 IV CONNECTORS · 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 10885403230615), received between May 14, 2019 and May 14, 2019 — 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
- Crack1
Patient problems
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) MEDICINE TRANSPLANT FLOOR THE BI-FUSE WAS BROKEN AT THE Y-SITE JUNCTION.
Patient problems: No Information
MAUDE report 8610413 ↗MalfunctionMay 14, 2019Crack; Crack
IT WAS REPORTED THAT THE BI-FUSE CONNECTOR CRACKED WHEN THE NURSE WENT TO CAP THE TUBING WITH AN ALCOHOL IMPREGNATED CAP ON THE GENERAL MEDICINE TRANSPLANT UNIT. THE CUSTOMER STATES THAT THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8609708 ↗
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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 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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