MaxZero MZ9313Recalls & reported problems
BD Switzerland Sàrl · Microbore tri-fuse Extension Set, 3 removable IV connectors 20 cm (8 in) · Class 2
All models of MaxZero (47)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403471292), received between Sep 15, 2025 and Jul 4, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Crack” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Crack3
- Break2
- Difficult to Flush1
- Insufficient Device Problem Information1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 4, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING . IT WAS REPORTED BY CUSTOMER THAT THEY HAD ABOUT 4 ISSUES WITH THIS PRODUCT TWO OF THEM INVOLVED TPN DELIVERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25710680 ↗MalfunctionApr 22, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PICU: 3 TRIFUSES HAVE CRACKED AND BROKEN WHEN ATTACHING TO PATIENT LINE IN THE LAST 24 HRS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956284 ↗MalfunctionApr 22, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PICU: 3 TRIFUSES HAVE CRACKED AND BROKEN WHEN ATTACHING TO PATIENT LINE IN THE LAST 24 HRS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956283 ↗MalfunctionApr 22, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PICU: 3 TRIFUSES HAVE CRACKED AND BROKEN WHEN ATTACHING TO PATIENT LINE IN THE LAST 24 HRS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956279 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT THE BD MAXZERO EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PIECE ON THE END BREAKS OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24071063 ↗MalfunctionJan 2, 2026Break
IT WAS REPORTED THAT THE BD MAXZERO EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS BEEN EXPERIENCING SOME ISSUES WITH THE PRODUCT MFG#MZ9313, PARTICULARLY WITH LOT#25095058. THE PIECE ON THE END BREAKS OFF. THIS HAS OCCURRED 10 TIMES LAST WEEK. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: CAN YOU PLEASE PROVIDE AN EXACT DATE OF INCIDENT IN THIS FORMAT MM-DD-YYYY? 12-01-2025 THROUGH 12-06-2025. WAS THERE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THIS EVENT? COMPLICATIONS ¿ PATIENT DID NOT RECEIVE FULL AMOUNT OF SEIZURE MEDICATION DUE TO LEAKING AT THE BROKEN PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23952523 ↗MalfunctionOct 23, 2025Obstruction of Flow; Obstruction of Flow
MalfunctionSep 15, 2025Difficult to Flush
TRIED MULTIPLE MAXZERO MICROBORE TRI-FUSE EXTENSIONS TODAY. ALL 3 HAD ONE LUMEN THAT WOULD NOT FLUSH DESPITE NUMEROUS ATTEMPTS. ALL 3 SETS WERE SAME LOT #.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051122 ↗
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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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