MaxZero MZ9273Recalls & reported problems
BD Switzerland Sàrl · Microbore tri-fuse extension set, 3 IV connectors, filter 152 cm (60 in) · Class 2
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10885403240850), received between Jul 7, 2020 and Mar 31, 2026 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (13 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
- Leak/Splash13
- Complete Blockage5
- Restricted Flow rate2
- Fluid/Blood Leak1
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Infusion or Flow Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24746207 ↗MalfunctionFeb 23, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21442737 ↗MalfunctionFeb 23, 2025Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21442734 ↗MalfunctionJan 7, 2025Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21091915 ↗MalfunctionSep 16, 2024
EXTENSION TUBING LUMEN WITH BLUE CLAMP WILL NOT FLUSH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20223755 ↗MalfunctionJan 2, 2024Leak/Splash; Leak/Splash
NO NEW INFORMATION MATERIAL#: MZ9273 LOT#: UNKNOWN, 22119145, 23049070, 23029243 IT WAS REPORTED BY THE CUSTOMER STATES THAT THE TRIFUSE IS LEAKING AROUND THE FILTER. VERBATIM: CUSTOMER STATES THAT THE TRIFUSE IS LEAKING AROUND THE FILTER. ADDITIONAL INFO RECEIVED 13-DEC-2023: I KNOW WE RECENTLY HAD PRIOR COMPLAINTS ABOUT THE PRODUCT WHICH WAS REF MZ9270 AFFECTED LOTS ARE: 22119145. 23049070. 23029243. WE HAVE THE AFFECTED PRODUCT IN BAGS FOR PICK UP IF SOMEONE COULD SWING BY OR SEND AN ADDRESS WE CAN SHIP TO. I WAS NOTIFIED BY YOUR IP NURSE CORRIE ANDERSON ON FRIDAY. I WENT AHEAD AND STARTED THE PIR. WE SHOULD BE ABLE TO ADD THIS INFORMATION TO THE REPORT AND COPY YOU INTO CORRESPONDENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18427285 ↗MalfunctionApr 13, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR LEAKED FROM THE TPN FILTER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DESCRIBE THE EVENT OR PROBLEM: PICC LINE INFUSING WITH TPN, SMOF LIPIDS, AND PRECEDEX. TPN FILTER ON PRE-MADE TRIFURCATE NOTED TO BE LEAKING FOR 2 DAYS IN A ROW."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16740455 ↗MalfunctionMar 27, 2023Fluid/Blood Leak
PICC LINE INFUSING WITH TPN, SMOF LIPIDS, AND PRECEDEX. TPN FILTER ON PRE-MADE TRIFURCATE NOTED TO BE LEAKING FOR 2 DAYS IN A ROW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16617843 ↗MalfunctionMar 8, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT DURING USE WITH BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) WAS OCCLUDED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LUMEN WITH WHITE CLAMP (USED FOR LIPID INFUSION) OF TRIFURCATE SET WILL NOT FLUSH. EXTENSION SET MICROBORE TRIFUSE, 3 BONDED MAXZERO¿ NEEDLE-FREE CONNECTORS, 0.2 MICRON FILTER, 3 SLIDE CLAMPS (RED, WHITE, BLUE) , SPIN MALE LUER LOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16500832 ↗MalfunctionAug 9, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TPN FILTER LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15192946 ↗MalfunctionJul 7, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON A CALL WITH THE CUSTOMER THEY REPORTED THAT THE NURSE CARING FOR THE BABY IN NICU NOTED THAT MZ9273 WAS LEAKING TPN THROUGH THE VENT. NO KNOWN HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14949792 ↗MalfunctionMay 7, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TPN FILTER LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14316067 ↗MalfunctionApr 1, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NICU COLLEAGUES HAVE REPORTED LEAKING FILTERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13972133 ↗MalfunctionMar 15, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 2 BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FILTER FOUND TO BE LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13773510 ↗MalfunctionMar 4, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IVF LEAKING AT PROXIMAL END OF TPN FILTER NEAR RED CLAMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13670816 ↗MalfunctionMar 4, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IVF LEAKING AT TPN FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13670490 ↗MalfunctionMar 4, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IVF LEAKING AT TPN FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13670261 ↗MalfunctionFeb 24, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING OF THE FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13595823 ↗MalfunctionFeb 9, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING FILTER OF TRIFUSE SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13497848 ↗MalfunctionMar 25, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT MICROBORE TRI-FUSE EXTENSION SET, 3 IV C HAD FLOW ISSUES.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: MZ9273 BATCH/ LOT #: UNKNOWNIT WAS REPORTED THAT THE TUBING AND FILTER WOULD NOT FLUSH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11573040 ↗MalfunctionJul 7, 2020Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT THE MICROBORE TRI-FUSE EXTENSION SET, 3 IV C WAS CLOGGED/BLOCKED/OCCLUDED AND EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO FLUSH IVF THROUGH FILTER LINE (RED CLAMP LUMEN). MULTIPLE ISSUES WITH THIS TUBING NOT FLUSHING. ADDITIONAL INFORMATION (CUSTOMER RESPONSE) 22-JUN-2020: EXTERNAL REFERENCE: MEDWATCH 4400240000-2020-8056 DATE OF INCIDENT: (B)(6)2020 DATE REPORTED: 15-JUN-2020. PART NAME: MAXZERO¿ EXTENSION SETS, PART NO.: MZ9273 , BATCH NO.: 18095666 , DESCRIPTION OF COMPLAINT: IT WAS REPORTED THAT TUBING WAS UNABLE TO FLUSH THROUGH FILTER LINE TO ASSIST IN PERFORMING A DETAILED INVESTIGATION, WE WOULD APPRECIATE YOUR ASSISTANCE IN OBTAINING INFORMATION RELATED TO THE QUESTION(S) BELOW: WHAT WAS THE DATES OF THE DEFECT? (B)(6)2020.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10241965 ↗
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.