MaxZero MZ9277Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10885403240799), received between Aug 19, 2019 and Jan 15, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Complete Blockage; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. THIS IS IN RESPONSE TO A CONVERSATION XX SET UP WITH BOSTON MASS IN WHICH THAT XX CONTRACT STATED THEY BELIEVE BD HAS A SOLVENT ISSUE, OF THE SOLVENT BEING USED IN EXCESS AND CAUSING THE CLAVE TO LEAK AND OR NOT BEING ABLE TO BE FLUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24081529 ↗
• MalfunctionJan 15, 2026Complete Blockage; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM THIS IS IN RESPONSE TO A CONVERSATION XX SET UP WITH BOSTON MASS IN WHICH THAT XX CONTRACT STATED THEY BELIEVE BD HAS A SOLVENT ISSUE, OF THE SOLVENT BEING USED IN EXCESS AND CAUSING THE CLAVE TO LEAK AND OR NOT BEING ABLE TO BE FLUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24081513 ↗
• MalfunctionJan 15, 2026Complete Blockage; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. THIS IS IN RESPONSE TO A CONVERSATION XX SET UP WITH (B)(6) IN WHICH THAT XX CONTRACT STATED THEY BELIEVE BD HAS A SOLVENT ISSUE, OF THE SOLVENT BEING USED IN EXCESS AND CAUSING THE CLAVE TO LEAK AND OR NOT BEING ABLE TO BE FLUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24081511 ↗
• 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 IS OCCURRING.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23680347 ↗
• MalfunctionJun 20, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301619 ↗
• MalfunctionJun 26, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) WAS OCCLUDED . THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM LIQUIDS ARE VERY DIFFICULT TO SPRAY THROUGH THE TUBING. WHEN DID THE INCIDENT OCCUR? DURING USE. IN THE EMERGENCY DEPARTMENT, IN THE ITS AND IN ENDOSCOPY, THERE HAVE BEEN AN INCREASING NUMBER OF PROBLEMS, REGARDLESS OF WHICH FLUID WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19618427 ↗
• MalfunctionMay 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT BD MAXZERO SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: DATE OF DELIVERY OF THE PRODUCT: PRODUCT DESCRIPTION: A 10 YEAR OLD CHILD PATIENT HAD A MAXZERO EXTENSION TUBE AT THE END OF A CANNULA PULLED ACROSS THE END OF THE CANNULA. THE BLUE PART OF THE VALVE PLUG CAME OFF. A SIMILAR SITUATION HAS OCCURRED ONCE BEFORE IN THE PAEDIATRIC WARD. WE HAVE ALSO TRIED THE EXTENSION HOSE OURSELVES AND THE BLUE END COMES OFF WITH A FIRM PULL. IS THIS A FEATURE OR A DETERIORATION IN QUALITY? IT DOES NOT SEEM A SAFE PRODUCT IN THE CHILDREN'S DEPARTMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19300858 ↗
• MalfunctionFeb 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR DISCONNECTS THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: THESE PRODUCTS ARE INSTALLED AT CHILREN POLIKLINIK, BUT PROBLEM ACCURED AT CHILDREN WARD THE VALVE GETS OFF THE EXTENSION WITH VERY LOW FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686546 ↗
• MalfunctionFeb 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR DISCONNECTS. THE FOLLOWING INFORMATION WAS RECEIVED BY INITIAL REPORTER WITH THE FOLLOWING VERBATIM: THESE PRODUCTS ARE INSTALLED AT CHILREN POLIKLINIK, BUT PROBLEM ACCURED AT CHILDREN WARD. THE VALVE GETS OFF THE EXTENSION WITH VERY LOW FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686226 ↗
• MalfunctionFeb 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR DISCONNECTED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: THESE PRODUCTS ARE INSTALLED AT CHILREN POLIKLINIK, BUT PROBLEM ACCURED AT CHILDREN WARD. THE VALVE GETS OFF THE EXTENSION WITH VERY LOW FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18656460 ↗
• MalfunctionNov 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S SEPARATES AND HAS LEAKAGE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: MAXZERO VALVE COMES OFF THE EXTENCION WITH VERY LOW FORCE. UPDATED ON 02.11.2023. FROM FOLLOW-UP: THERE HAS NOT BEEN LEAK AT THE CHILDREN EMERGENCY POLICLINIC BUT CUSTOMER MENTIONED THAT HE HAD NOTICED THE VALVE QUITE EASILY, WITH LOW FORCE GETS OFF THE EXYENCION. BUT WHEN PATIENT WAS FORWARDED TO BED WARD, THE VALVE HAD COME OF THE EXTENSION AND IT HAD LEAK THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212120 ↗
• MalfunctionNov 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR DISCONNECTED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: THESE PRODUCTS ARE INSTALLED AT CHILREN POLIKLINIK, BUT PROBLEM ACCURED AT CHILDREN WARD. THE VALVE GETS OFF THE EXTENSION WITH VERY LOW FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18207790 ↗
• MalfunctionNov 7, 2023Leak/Splash; Failure to Disconnect; Leak/Splash; Failure to Disconnect

  NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18089271 ↗
• MalfunctionOct 3, 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: PRODUCT EXTENSION HAD BROKEN BELOW THE NEEDLEFREE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865583 ↗
• MalfunctionNov 14, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTORS HAD FLOW ISSUES WHILE INJECTING RADIOACTIVE TRACERS, AS WELL AS DURING THE FLUSHING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE MAXZERO EXTENSION TUBING CREATES BACK SPLASH WHEN INJECTING RADIOACTIVE TRACERS. THIS CAUSES SIGNIFICANT CONTAMINATION TO HE PATIENT AND UNNECESSARY EXPOSURE TO THE CAREGIVER STAFF AND NURSING TEAMS ON THE FLOOR. IN ADDITION TO THE CONTAMINATION, THE TRACER, EVEN WHEN FLUSHED, COLLECTS IN THE MAXZERO BLUE HUB WHICH REDUCES THE IMAGE QUALITY OF OUR CARDIAC STRESS PATIENTS AND POTENTIALLY EXPOSES NURSING TEAMS ON THE FLOOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15795126 ↗
• MalfunctionAug 5, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 6 BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD TWO MAXZERO IV CONNECTORS FAIL IN JUNE. THERE WAS A LEAK AT THE MAX ZERO HUB, AND NEEDED TO BE CHANGED THREE TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15175226 ↗
• MalfunctionMay 19, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED SPONTANEOUS DISCONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT DOES NOT STAY IN PLACE WHEN CONNECTED TO NFC OR CANNULA. THE LUER LOCK DID NOT KEEP THE PRODUCT IN PLACE AND SYRINGE DID NOT STAY IN THE NFC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14438631 ↗
• MalfunctionApr 5, 2022Complete Blockage; Leak/Splash; Incomplete or Inadequate Connection; Complete Blockage; Leak/Splash; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT 1 BD MAXZERO¿ EXTENSION SET WAS LOOSE, LEAKED AND WAS BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE USER REPORTED THAT THE NEW MAXZERO EXTENSION TUBING IS CAUSING MANY ISSUES. THEY ARE HAVING PROBLEMS DRAWING BLOOD OUT OF THIS TUBING WITH THE IV START, IT IS VERY STIFF AND TIGHT JUST PUSHING SALINE THROUGH THIS TUBING AND BECAUSE THEY ARE SO DIFFICULT TO PUSH ANYTHING THROUGH THE TUBING IS POPPING OFF AT THE IV HUB, WHICH LEAVES AN OPEN IV AND BLOOD IS THEN DRIPPING OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015339 ↗
• MalfunctionNov 6, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MICROBORE EXTENSION SET EXPERIENCED SPONTANEOUS DISCONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT IS NOT SUITABLE FOR USE BECAUSE, FOR EXAMPLE, WHEN RINSING, THE SYRINGE POPS OUT, EVEN IF IT IS WELL INSERTED IN THE CONNECTOR. IN ADDITION, WHEN IT UNDERGOES A CONTINUOUS INFUSION AND IS CAREFULLY ATTACHED THEN IT COMES OFF. IN ADDITION, VARIOUS SYRINGES (E.G., LUERLOCK AND PLAIN, ETC.) ARE NEEDED TO ENSURE THAT THE DRUG AND FLUID REACH THEIR DESTINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756016 ↗
• MalfunctionNov 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD MAXZERO¿ EXTENSION SETS, THE DEVICE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE ENCOUNTERED A LEAK WHILE USING BD 3 ML LUER LOCK SYRINGE (REF (B)(4)) WHEN ATTACHED TO THE BD MAXZERO MICROBORE EXTENSION SET TUBING (REF MZ9277). CEFTAZIDIME WAS INFUSING IN A PATIENT OVER 30 MINUTES AND AT THE END OF INFUSION, FLUID WAS NOTED ON THE SYRINGE, TUBING, AND IV SYRINGE PUMP. PATIENT WAS NOT HARMED. HOWEVER PATIENT WAS BEING TREATED FOR BLOOD CULTURE POSITIVE BACTEREMIA AND WE BELIEVE THE ENTIRE DOSE OF ANTIBIOTIC WAS NOT ADMINISTERED TO THE PATIENT DUE TO THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12746148 ↗
• MalfunctionOct 21, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR HAD SPONTANEOUS DISCONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) : "THE PRODUCT IS NOT SUITABLE FOR USE BECAUSE, FOR EXAMPLE, WHEN RINSING, THE SYRINGE POPS OUT EVEN THOUGH IT IS WELL INSERTED IN THE CONNECTOR. IN ADDITION, WHEN IT UNDERGOES A CONTINUOUS INFUSION AND IS CAREFULLY ATTACHED THEN IT COMES OFF." DOUBT; WITH THE USE OF THIS PRODUCT, VENOUS CANNULAS BECOME MORE PRONE TO CLOGGING. IN ADDITION, VARIOUS SYRINGES (E.G., LUERLOCK AND PLAIN, ETC.) ARE NEEDED TO ENSURE THAT THE DRUG AND FLUID REACH THEIR DESTINATION. THIS USAGE PROBLEM HAS BEEN DETECTED IN SEVERAL WARDS AT THE NEW CHILDREN'S HOSPITAL. PREVIOUSLY, WE HAD A REF 385102 BD Q-IGNITION, THERE WERE NO SIMILAR PROBLEMS WITH THIS. LOT-BATCH NUMBER: 20067210. FOR INFORMATION TO BE SUPPLIED BY THE SUPPLIER AND THE PRODUCT COMPLAINANT: HEY, THIS IS A COMPLAINT ABOUT THE PRODUCT YOU HAVE SUPPLIED. AFTER ALL, YOU WILL REPLACE DEFECTIVE PRODUCTS WITH FLAWLESS PRODUCTS AT YOUR OWN EXPENSE. THE ADVERTISED PRODUCT IS AVAILABLE, SO IF YOU WANT IT EXAMINED, YOU CAN PICK UP THE PRODUCT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12675851 ↗
• MalfunctionAug 18, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT THE MICROBORE EXTENSION SET, IV CONNECTOR WAS BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM HAVING THE ED RNS WORK WITH THE MACROBORE TUBING THAT IS CURRENTLY IN THE KITS USED ON THE INPATIENT SIDE TO SEE IF THEIR CONCERNS ARE ADDRESSED WITH THIS PRODUCT. HOWEVER, I HAVE A NEW ED RN WHO TRANSITIONED FROM THE INPATIENT SIDE RECENTLY AND SHE ALSO HAD COMPLAINTS ABOUT THIS TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339514 ↗
• MalfunctionAug 16, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT MICROBORE EXTENSION SET, IV CONNECTOR HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEE FEEDBACK BELOW ¿ I HAVE FOUND THAT THIS TUBING IS NOT AS FUNCTIONAL AS THE PREVIOUS TUBING WAS. THE TUBING HAS A SMALLER INNER DIAMETER, WHICH LEADS TO THE FOLLOWING ISSUES: DIFFICULTY DRAWING LABS. HEMOLYZED LABS. RESISTANCE WHEN FLUSHING TUBING AND ADMINISTERING MEDICATION. (THIS WOULD MAKE ADMINISTERING ADENOSINE OR EPI IN A CRITICAL SITUATION VERY DIFFICULT AND A POTENTIAL SAFETY CONCERN). IV BOLUSES TAKE SEVERAL HOURS TO INFUSE INSTEAD OF 30ISH MINUTES (EVEN WHEN THE IV IS LARGE BORE LIKE 18G). PATIENTS WITH CT SCANS THAT REQUIRE CONTRAST ARE UNABLE TO USE THESE IV'S/TUBING BECAUSE OF THE LOW FLOW RATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329024 ↗
• MalfunctionAug 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Free or Unrestricted Flow; Incorrect, Inadequate or Imprecise Result or Readings; Free or Unrestricted Flow

  IT WAS REPORTED THAT MICROBORE EXTENSION SET, IV CONNECTOR EXPERIENCED AIR BUBBLES AND HEMOLYSIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEE FEEDBACK BELOW ¿ HARD TO DRAW BLOOD, LOTS OF RESISTANCE & HEMOLYZED SAMPLES. WHEN DRAWING BLOOD, AIR ALSO BEING DRAWN IN (BUBBLES IN LINE) - TUBES NOT FILLING - QNS FROM LAB ON BLUE TOPS. NEED TO USE SYRINGES TO DRAW BLOOD (CAN'T USE VACUTAINER) & THEN NEED TRANSFER DEVICE OR NEEDLE TO TRANSFER BLOOD - NOT AS SAFE! FLUID BOLUSES PER GRAVITY DO NOT DRIP! NEED TO USE PUMP TUBING FOR FLUIDS. ONLY ABLE TO INFUSE 1 L AT A TIME USING PUMP - LOTS OF RESISTANCE TO FLUID BOLUS & REPEAT ALARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329002 ↗
• MalfunctionAug 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT IN THE NEONATAL ICU THE 3ML SYRINGES WERE LEAKING WITH THE NEEDLELESS VALVE AND NEEDLELESS VALVE MICROBORE TUBING. THE CUSTOMER STATES THAT THERE WAS NO MEDICAL INTERVENTION OR ADVERSE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8907831 ↗