MaxZero MZ9275Recalls & reported problems
BD Switzerland Sàrl · Microbore quad-fuse extension set, 4 IV Connectors, 15cm (6in) · Class 2
Quick summary
This BD MaxZero extension set is a short tubing set with multiple connectors used to deliver fluids through an IV line. The 25 reports mostly describe cracking or breaking at the connectors, sometimes causing leaks or disconnections and brief interruptions to infusions, and mention no deaths and 1 injury. No recalls name this device.
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
- 25
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10885403240768), received between Nov 15, 2018 and Jul 21, 2025 — classified as 1 injury, 24 malfunctions.
The most frequently reported specific device problem is “Break” (9 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
- Break9
- Crack8
- Leak/Splash5
- Material Separation4
- Defective Component3
- Activation, Positioning or Separation Problem2
- Complete Blockage2
- Separation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient3
- Bacteremia2
- Insufficient Information1
- No Information1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS DISCONNECTING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT BREAKAGE IS OCCURRING AT THE LUER LOCK CONNECTION AND DISCONNECTIONS OF THE BONDED NEEDLELESS VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22560176 ↗MalfunctionJul 21, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22560172 ↗MalfunctionFeb 11, 2025Break; Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21355954 ↗MalfunctionJul 29, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19851879 ↗MalfunctionJul 23, 2024Leak/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: REPORTED ISSUE: WHEN BEDSIDE RN WENT TO DISCONNECT THE QUADFUSE SET) FROM THE PATIENT'S CATHETER (PORT), THE LUER CONNECTOR BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19806557 ↗MalfunctionMay 28, 2024Leak/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: REPORTED ISSUE: (B)(6): PT EXHIBITING WAT BEHAVIORS INCLUDING, SBS GREATER THAN 1, DIFFICULT TO CONSOLE, AND GAGGING. (B)(6): PT HAD BEEN SLEEPING, RESTING, WOKE UP IN DISTRESS AFTER FIRST SET OF ETT RETAPE. (B)(6): DILAUDID DRIP CONTINUED ALARM OF "OCCLUSION", MYSELF AND RN (B)(6) ASSESSED TUBING, AND FOUND QUAD FUSE HAD CRACKED, BEING THE CAUSE OF THE OCCLUSION. ALARIS ALARM HAD NOT BEEN ALARMING ALL NIGHT UNTIL EVENT AND HAD BEEN ALARMING A TON SUDDENLY. (B)(6): QUAD FUSE MAY BE DISFUNCTIONAL. OTHER RN'S AROUND UNIT STATING QUAD FUSES HAD BEEN CRACKING/DYSFUNCTIONAL AS WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19412499 ↗MalfunctionMay 9, 2024Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19278989 ↗MalfunctionMay 6, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) WAS BREAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM COLLAR OF QUAD-FUSE BROKE WHEN DISCONNECTED FROM LINE. UNABLE TO REUSE. B: PATIENT HAD SEDATION AND MIVF INFUSING THROUGH QUAD-FUSE SO THERE AS A BRIEF INTERRUPTION IN THE INFUSIONS WHILE A NEW QUAD-FUSE WAS OBTAINED AND PRIMED. A: NO APPARENT ADVERSE RESULTS R: AS THIS IS THE 2ND QUAD-FUSE THAT HAS BROKEN FOR ME IN 2 DAYS AND MANY STAFF HAVE REPORTED THIS IS A COMMON ISSUE, I WOULD RECOMMEND LOOKING INTO A REPLACEMENT PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19251843 ↗MalfunctionDec 10, 2023Defective Component; Defective Component
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: UADFUSE CONNECTOR CRACKED UPON REGULAR USE. NO EXCESSIVE FORCE APPLIED. TPN, DEX, HEPARIN, D10 FLUIDS HAVE BEEN USED WITH THE QUADFUSE. 11/28/23
Patient problems: Insufficient Information
MAUDE report 18298689 ↗MalfunctionMay 15, 2023Break; Crack; Break; Crack
InjuryMay 15, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD MAXZERO¿ MULTI-FUSE EXTENSION SETS WITH NEEDLELESS CONNECTOR HAD ISSUES WITH THE HUB CRACKING AND BREAKING OFF. AS A RESULT, THE PATIENT DEVELOPED CLABSI SHORTLY AFTER, BUT NO FURTHER INFORMATION ON THE TREATMENT WAS PROVIDED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOW WE ARE HAVING AN ISSUE WITH THE QUAD LUMEN EXTENSION SET (CAT # MZ9275). YES, THEY ARE ALL ON PATIENTS AND HAVE HAD IT HAPPEN AFTER BEING ON FOR ONLY FOR A SHIFT. CAN YOU PLEASE DESCRIBE THE ISSUE? THE HUB CRACKED AND BROKE OFF. ARE THERE ANY ADVERSE EVENT OR SERIOUS INJURIES REPORTED ON PATIENT OR HEALTH PROFESSIONAL? CLABSI REPORTED SHORTLY AFTER THIS PATIENT AROUND THE SAME TIME AS DISCOVERED THE CRACK WHAT TYPE OF PROCEDURE WAS BEING PERFORMED? N/A. WHAT WAS THE MEDICATION BEING USED? IV FLUIDS AND VASOPRESSIN. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? YES UNSURE OF WHAT . WAS THERE ANY EXPOSURE TO BLOOD/BODILY FLUID/IV SOLUTION? YES".
Patient problems: Bacteremia
MAUDE report 16931950 ↗MalfunctionMar 1, 2023Crack; Separation Problem; Crack; Separation Problem
IT WAS REPORTED THAT DURING USE WITH BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR IT DISCONNECTED FROM FEM LINE AND THE THREADED COLLAR CONNECTOR WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD MAXZERO QUAD-FUSE DISCONNECTED TO DRAW LABS FROM FEM LINE. UPON RECONNECTING, THE THREADED COLLAR CONNECTOR CRACKED. REMAINED SECURED ON THE FEM LINE, BUT UPON INSPECTION SEVERAL CRACKS WERE SEEN THROUGHOUT COLLAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16463646 ↗MalfunctionFeb 27, 2023Crack; Crack
IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR CRACKED WHEN REATTACHED TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "QUAD FUSE CRACKED WHEN BEING REATTACHED TO PATIENT BY NNP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16449705 ↗MalfunctionFeb 27, 2023Break; Break
IT WAS REPORTED THAT WHILE TRYING TO RECONNECT THE QUAD FUSE TO PIV WITH BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR THE QUAD FUSE BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS RN WAS GOING TO RECONNECT QUAD FUSE TO PIV, THE ATTACHMENT SITE OF THE QUAD FUSE BROKE IN MULTIPLE PIECES. WE ATTAINED A NEW QUAD FUSE AND SEQUESTERED THE BROKEN QUAD FUSE AND WILL GIVE IT TO RN MANAGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16449081 ↗MalfunctionFeb 27, 2023Crack; Crack
IT WAS REPORTED THAT DURING USE WITH BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR THAT "THE DISTAL MOST PART OF THE QUAD THAT ATTACHES TO THE PATIENT WAS CRACKED". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT "THE DISTAL MOST PART OF THE QUAD THAT ATTACHES TO THE PATIENT WAS CRACKED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16449075 ↗MalfunctionFeb 27, 2023Crack; Material Separation; Crack; Material Separation
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR SCREW ATTACHMENT WAS CRACKED AND IT DISCONNECTED FROM THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT HAS A DUAL LUMEN PEDIATRIC POWER PICC. WHEN I DISCONNECTED THE QUAD FUSE FROM THE WHITE PORT OF THE PICC, WHICH WAS RUNNING SORENSON AND LIPIDS, THE SCREW ATTACHMENT AT THE END OF THE QUAD FUSE HAD A CRACK IN IT AND DISCONNECTED FROM THE REST OF THE LINE. NEW QUAD FUSE IMMEDIATELY PRIMED AND SWAPPED OUT. NOTIFIED AND SHOWED CHARGE NURSE WHERE LINE DEFECT WAS. NO LEAKAGE AROUND THE OLD QUAD FUSE DETECTED BEFORE IT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16443472 ↗MalfunctionFeb 24, 2023Break; Separation Problem; Break; Separation Problem
IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTORS LUER-LOCK COLLAR WAS BROKEN AND FELL OFF THE QUAD FUSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UPON DISCONNECTING AND ATTEMPTING TO RECONNECT QUAD FUSE TO FEMORAL LINE, THE CONNECTING COLLAR WITH THREADS FELL OFF OF QUAD FUSE. UPON INSPECTION, NOTICED COLLAR WAS BROKEN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16438859 ↗MalfunctionFeb 23, 2023Break; Break
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: WHEN CHECKING CONNECTIONS ON MY UVC LINES, A BROKEN QUAD-FUSE WAS FOUND. NO LEAKING IV FLUIDS, BUT CHIPPED CONNECTOR WHERE THE QUAD FUSE ATTACHED TO THE PORT OF A CENTRAL LINE. FULL LINE CHANGE DONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16433296 ↗MalfunctionFeb 23, 2023Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT DURING USE WITH BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR IT WAS DISCOVERED TO BE BROKEN AND THERE WAS COMPONENT SEPARATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE THIS RN WAS HANGING NEW BAG OF DEX, FOLLOWED LINE TO PATIENT AND FOUND QUADFUSE IN BROKEN, DISCONNECTED FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16432832 ↗MalfunctionFeb 23, 2023Crack; Material Separation; Crack; Material Separation
IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS CRACKED AND DISCONNECTED FROM THE PATIENT WHEN CHANGING THE TPN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "QUADFUSE COLLAR FOUND TO BE CRACKED AND CAME DISCONNECTED FROM PT WHEN CHANGING TPN LINE. NEW QUADFUSE PRIMED AND CHANGED WITH NEW TPN BAG. NO CONTAMINATION OCCURRED TO PT AS BROKEN QUADFUSE WAS FROM LINE THAT WAS DUE TO BE CHANGED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16427852 ↗MalfunctionFeb 2, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR TUBING WAS OCCLUDED DURING THE FLUSH AND DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE HAVE BEEN SEVERAL RECENT EVENTS WITH THE MAXZERO QUADFUSES. THE TUBING IS UNABLE TO BE FLUSHED THOUGH DURING SETUP AND ALSO NOTED TO BE OCCLUDED DURING USE. THIS IS DESPITE THE STAFF HAVING AWARENESS AND UTILIZING THE TWO STEP CONNECTION PROCESS. IT IS A PAIN POINT AS THESE ARE MOST FREQUENTLY USED FOR HIGH ACUITY PATIENTS FOR CRITICAL MEDICATION INFUSIONS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16288069 ↗MalfunctionMay 19, 2022Break; Break
IT WAS REPORTED THAT THE BD MAXZERO¿ EXTENSION SET EXPERIENCED BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THAT MULTIPLE LINES CONNECT TO SNAPPED AND BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14438845 ↗MalfunctionJul 6, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE ATTACHING THE MICROBORE QUAD-FUSE EXTENSION SET, 4 IV TO "BROVIAC", A CRACK WAS NOTICED IN THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOTICED A CRACK IN THE HUB WHEN ATTACHING LINE TO BROVIAC. DISCONNECTED AND REPLACED"
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10237679 ↗MalfunctionNov 5, 2019Break; Material Separation; Insufficient Device Problem Information; Break; Material Separation; Insufficient Device Problem Information
IT WAS REPORTED THAT TRIFUSE EXTENSION SET BROKE OFF DURING A CONTINUOUS INFUSION OF VASOPRESSIN. THE CUSTOMER STATED THE EXTENSION SET BROKE AT THE CONNECTION TO AN UNSPECIFIED MATING DEVICE. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTIONS REQUIRED PER CUSTOMER. THE EVENT OCCURRED IN THE CTICU. ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 9281173 ↗MalfunctionNov 15, 2018Crack; Crack
THE CUSTOMER REPORTED THAT WHEN CHECKING THE PATIENT IV LINES A CRACK WAS NOTED AT THE LUER CONNECTOR. THE NURSE ATTEMPTED TO DISCONNECT THE EXTENSION SET HOWEVER IT CRACKED FURTHER AND WAS DIFFICULT TO REMOVE. THERE WAS NO REPORT PATIENT HARM. THE EVENT OCCURRED NICU.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8075559 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.