MaxZero MZ5316Recalls & reported problems
BD Switzerland Sàrl · Pressure Rated Bi-Fuse Extension Set, 2 IV Connectors, 18 cm (7 in) · Class 2
All models of MaxZero (47)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403471278), received between Jul 6, 2023 and Feb 6, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Component2
- Leak/Splash2
- Detachment of Device or Device Component1
- Extra Components1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD EXTENSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT WHILE ATTACHING PT'S IV TO MAXZERO LUMEN DUAL EXTENSION, THE HUB FELL OFF. ALSO LEAKING NOTED AT THE Y-SITE OF THE LUMEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21325608 ↗MalfunctionFeb 26, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18779158 ↗MalfunctionOct 24, 2023Defective Component; Defective Component
NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL #: MZ5316 BATCH #: 23039122 IT WAS REPORTED BY THE CUSTOMER THAT WHEN RN PLACED THE EXTENSION ON THE IV CATHETER IN PATIENT'S ARM, BLOOD IMMEDIATELY STARTED COMING OUT OF THE END OF THE SITE. UPON FURTHER INVESTIGATION, THE NURSE REALIZED THAT THE END OF THE Y-SITE HAD BROKEN OFF. VERBATIM: REF. # (B)(4). RN PLACED IV IN A NEW ADMISSION LABOR PATIENT, WHEN SHE PLACED THE EXTENSION ON THE IV CATHETER IN PATIENT'S ARM, BLOOD IMMEDIATELY STARTED COMING OUT OF THE END OF THE SITE. UPON FURTHER INVESTIGATION, THE NURSE REALIZED THAT THE END OF THE Y-SITE HAD BROKEN OFF. SHE CLAMPED THE LINE AND PROCEEDED TO CHANGE OUT THE Y-SITE FOR ANOTHER. THE PRODUCT AND IT'S WRAPPER WERE KEPT FOR INVESTIGATION AFTERWARDS. CATALOG # MZ5316 LOT / SERIAL # (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17996429 ↗MalfunctionOct 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17954513 ↗MalfunctionJul 6, 2023Defective Component; Extra Components; Defective Component; Extra Components
IT WAS REPORTED THAT DURING USE WITH BD EXTENSION SET 2-WAY MAXZERO¿ THE DEVICE WAS MISASSEMBLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV SALINE LOCK HAS THREE PORTS INSTEAD OF TWO PORTS AND A PLACE TO ATTACH THE SALINE LOCK TO THE IV HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17276285 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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