MaxZero MZ9266Recalls & reported problems
BD Switzerland Sàrl · Microbore tri-fuse extension set, 3 IV connectors 10 cm, (4.0 in) · Class 2
Quick summary
This BD MaxZero tri-fuse extension set has 131 adverse event reports on record, with 1 death and 1 injury. The reports mostly describe fluid leaking from the set, parts breaking or cracking, and ports that are blocked and will not flush. Most say no clinical signs or patient impact were reported. There are no recalls naming this device. The last 12 months show 9 reports, compared with 26 in the 12 months before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 130
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 10885403240782), received between Jul 12, 2018 and Sep 21, 2026 — classified as 1 death, 1 injury, 128 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (49 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak49
- Break25
- Leak/Splash22
- Complete Blockage13
- Backflow10
- Crack10
- Material Separation7
- Defective Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions66
- No Consequences Or Impact To Patient48
- No Information6
- No Known Impact Or Consequence To Patient6
- Insufficient Information4
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 130 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834925 ↗MalfunctionApr 21, 2026Complete Blockage
IT IS REPORTED, FLUSHING ONE OF MY TRI-FUSE PORTS (BLUE PORT) AND MET RESISTANCE. WAS UNCLAMPED WITH NO KINKS AND WOULD NOT FLUSH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24943418 ↗MalfunctionFeb 26, 2026Break
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE BABY WENT TO MRI AND IV FLUIDS DC DURING PROCEDURE. WENT TO RECONNECT THE TRIFUSE, AND THE LEUR LOCK END BROKE OFF DURING RECONNECTION. POSEY FLOW WAS ON THE OTHER END OF THE LINE, SO THERE WAS NO OPENING INTO THE LINE (STAYED CLOSED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24462483 ↗MalfunctionJan 26, 2026Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNFORTUNATELY, I DO NOT HAVE A TON OF INFORMATION REGARDING THE ACTUAL ISSUES BESIDES LEAKING. NON-BONDED JLOOP X2 - MZ9277.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24184861 ↗MalfunctionJan 26, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24184860 ↗MalfunctionJan 26, 2026Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNFORTUNATELY, I DO NOT HAVE A TON OF INFORMATION REGARDING THE ACTUAL ISSUES BESIDES LEAKING. BONDED TRI-FUSE X3 - MZ9266.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24184437 ↗MalfunctionDec 1, 2025Crack; Crack
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS CRACKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT LEAKING BELOW THE HUB TOWARDS THE EXTENSION SET AND FOR CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23680342 ↗MalfunctionNov 21, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT NOTICED A SMALL AMOUNT OF WETNESS ON LINEN UNDER 3-WAY T-CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23621691 ↗MalfunctionSep 2, 2025Crack; Crack
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT IS REPORTING CRACKING AT THE MALE LUER HUB OF EXTENSION SET MZ9266.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22929805 ↗MalfunctionAug 14, 2025Nonstandard Device; Material Separation; Nonstandard Device; Material Separation
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS LOOSE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT LURE LOCK WAS SPINNING AND NOT SECURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22810777 ↗MalfunctionAug 10, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIMIT WAS REPORTED BY CUSTOMER THAT "WHEN PREPPING A TRI-FUSE CONNECTOR FOR LINE CHANGE, IT WAS NOTED THAT THE WHITE PORT ON THE TRI-FUSE WOULD NOT FLUSH THROUGH."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22767879 ↗MalfunctionJul 10, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXZERO MICROBORE EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT WHEN DISCONNECTING TRIFUSE NOTED THAT CONNECTOR PIECE WAS CRACKED AND COMPLETELY BROKE OFF WHEN REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22465764 ↗MalfunctionJul 7, 2025Break; Break
IT WAS REPORTED THAT BD MICROBORE TRI-FUSE EXTENSION SET CONNECTOR CRACKED AND BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD ANOTHER XXXX FILED ON THE TRIFUSE EXTENSION SETS BRAKING. PLEASE REVIEW BELOW WHEN DISCONNECTING TRIFUSE NOTED THAT CONNECTOR PIECE WAS CRACKED AND COMPLETELY BROKE OFF WHEN REMOVED. WHAT DISCONNECTING TO D/C CVC SO NO ISSUE AROSE WITH MEDICATIONS OR FLUIDS. NO LOT # KNOW DUE TO PRODUCT HANDING FOR 4 DAYS PRIOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22420851 ↗MalfunctionJun 30, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE CONNECTION PIECE OF THE TRIFUSE THAT CONNECTS TO THE CLAVE OF THE CENTRAL LINE SNAPPED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22354296 ↗MalfunctionJun 20, 2025Crack; Crack
IT WAS REPORTED THAT THE BD MAXGUARD MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LEUER END OF THE BD MAXPLUS TRI-FUSE EXTENSION SET WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22301952 ↗MalfunctionJun 20, 2025Crack; Crack
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LEUER END OF THIS EXTENSION SET WAS FOUND TO BE CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22301941 ↗MalfunctionJun 2, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXZERO MICROBORE TRI-FUSE EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT FLUSHED LINE, NOTED LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22124589 ↗MalfunctionMay 21, 2025Leak/Splash; Leak/Splash
MalfunctionMay 5, 2025Material Separation; Separation Problem; Material Separation; Separation Problem
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS SEPARATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21962298 ↗MalfunctionApr 22, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: THE BD MAXZERO MICROBORE TRI-FUSE EXTENSION SET, SCREW PIECE AT THE END BROKE OFF WHILE DRAWING LABS FROM A PEDS POWER PICC. ALSO, THE BLUE BD MAXZERO NEEDLELESS CONNECTOR WOULD NOT TWIST OFF AND THERE WERE NO HEMOSTATS AT THE BEDSIDE. CALLED FOR HELP AND REPLACED THE TRI-FUSE AND CONNECTOR. VANCOMYCIN THROUGH DRAWN ON TIME, STERILE CONNECTIONS MAINTAINED AND NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21887304 ↗MalfunctionMar 31, 2025Break; Break
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM THE BEDSIDE RN WAS ASSESS THE PATIENT AND FOUND THAT THE BD MAX ZERO TRI-FUSE EXTENSION SET WAS BROKEN. PER NURSE, NO BLOOD WAS LOST. PRODUCT#: MZ9266.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21735605 ↗MalfunctionMar 18, 2025Break; Break
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM THE BEDSIDE RN WAS ASSESS THE PATIENT AND FOUND THAT THE BD MAX ZERO TRI-FUSE EXTENSION SET WAS BROKEN. PER NURSE, NO BLOOD WAS LOST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21639254 ↗MalfunctionMar 3, 2025Break; Break
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS MISSING A COMPONENT. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE TRIFUSE EXTENSION SET WAS FOUND WITH ONE OF THE MAXZERO CONNECTORS MISSING, WHICH APPEARED TO HAVE BROKEN OFF COMPLETELY WITHOUT ANY PULLING OR REMOVAL BY FORCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21511277 ↗MalfunctionFeb 25, 2025Break; Break
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT ONE OF THE TRIFUSE BROKE OFF FROM THE CATHETER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21460999 ↗MalfunctionFeb 18, 2025Crack; Crack
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS BREAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT HERE WERE CRACKS ON THE LUER LOCK PORTION OF TRIFUSE WHILE IN USE ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21400450 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.