MaxZero MZXT9001Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10885403240805), received between Aug 2, 2018 and Jun 5, 2026 — classified as 1 death, 24 malfunctions.

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

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.

• MalfunctionJun 5, 2026Connection Problem

  IT WAS REPORTED THAT THE BD MAXZERO EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS VERY DIFFICULT THE SCREW THE EXTENSION SET ONTO THE IV CATHETER HUB. THE EXTRA EFFORT TO GET IT STARTED MAKES YOU WORRY YOU'RE GOING TO PULL OUT THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417535 ↗
• MalfunctionFeb 20, 2026Connection Problem

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406842 ↗
• MalfunctionFeb 9, 2026Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THERE WAS CAUSING FLUID TO LEAK IN A PUDDLE ON THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24294038 ↗
• MalfunctionFeb 9, 2026Fluid/Blood Leak; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24294017 ↗
• DeathFeb 2, 2026Leak/Splash

  IT IS REPORTED LEAKAGE. DESCRIPTION: WE RECENTLY EXPERIENCED A SENTINEL EVENT INVOLVING THE BD MAXZERO MICROBORE EXTENSION SET (REF: MZXT9001). THE CONNECTION POINT LEAKED, WHICH LIKELY IMPACTED THE ADMINISTRATION OF CRITICAL MEDICATIONS. MEDWATCH: BD MAXZERO MICROBORE EXTENSION SET (REF: (B)(6)) CONNECTED TO BD ALARIS PUMP INFUSION SET (REF: (B)(6)) CONNECTION POINT BETWEEN INFUSION SET AND EXTENSION SET WERE CONNECTED BUT LEAKED. PATIENT WAS UNDERGOING PROCEDURE REQUIRED ANTICOAGULATION MEDICATIONS UNCLEAR IF MEDICATIONS WERE FULLY INFUSED DUE TO LEAK. LAB VALUES ALIGN WITH INSUFFICIENT MEDICATION. PATIENT CLOTTED AND CODED. EXTENSIVE EFFORTS WERE UTILIZED BUT CARE WAS ULTIMATELY WITHDRAWN AND PATIENT PASSED. PT CODE: 1762. DEVICE CODE: 1250. REF REPORT: MW5182215. ADDITIONAL INFORMATION THE PATIENT WAS STABLE PRIOR TO THIS ENCOUNTER INVOLVING THIS PRODUCT. DATE OF THE EVENT 1-6-2026. LOT NUMBER ASSOCIATED WITH THE PRODUCT LOT 25029194. MEDICATION OR FLUID IN USE AT THE TIME OF THE EVENT: SODIUM CHLORIDE 0.9 PERCENT AND HEPARIN IMPACT TO THE PATIENT-PLEASE DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION, OR NEGATIVE OUTCOME: LIFE SUSTAINING MEASURES, DEATH (CARE WITHDRAWN).

  Patient problems: Cardiac Arrest

  MAUDE report 24231091 ↗
• MalfunctionJun 9, 2025Leak/Splash; Leak/Splash

  SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22173068 ↗
• MalfunctionFeb 28, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BD MAXZERO MULTI FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR BROKE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT SPIN COLLAR ON THE MALE LEUR OF THE EXTENSION SET IS COMING OFF DURING ATTACHMENT TO THE IV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21499363 ↗
• MalfunctionJan 30, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD MAXZERO MULTI FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT HAVING ISSUES WITH MFR# (B)(4) BD MAXZERO EXTENSION SET. BOTH (RADIOLOGIST) AND (ANESTHESIA) ARE HAVING ISSUES WITH THIS PRODUCT. COMPLAINTS ARE: THE PRODUCT IS DIFFICULT TO ATTACH DURING A VERY TRICKY TIME DURING THE PROCEDURE. THE NEW VALVE AT THE END OF THE TUBING MAKES IT VERY DIFFICULT TO ATTACH TO THE NEEDLE. THEY ARE DIFFICULT TO FLUSH AND FEEL THAT THEY ARE A SAFETY ISSUE. THEY ARE NOT ABLE TO PERFORM CERVICAL EPIDURALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21279571 ↗
• MalfunctionOct 2, 2024Leak/Splash; Activation, Positioning or Separation Problem; Leak/Splash; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BD MAXZERO MULTI FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: VERBATIM: PRODUCT PROBLEM - THE T CONNECTOR COMES APART AND IS NOT SECURE. - MULTIPLE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351874 ↗
• MalfunctionSep 12, 2024Break; 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 VERBATIM: IT WAS REPORTED BY CUSTOMER THAT T PIECE CONNECTOR FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200728 ↗
• MalfunctionSep 11, 2024Break; 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 T PIECE CONNECTOR FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191310 ↗
• MalfunctionSep 11, 2024Break; 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 T PIECE CONNECTOR FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191168 ↗
• MalfunctionSep 10, 2024Break; 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: T PIECE CONNECTOR WAS FOUND BROKEN IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182058 ↗
• MalfunctionSep 9, 2024Leak/Splash; Material Separation; Leak/Splash; Material Separation

  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: THE NON FUSED SPIN COLLAR THAT SCREWS ON TO THE LUER LOCK PF THE CATHETER IS COMING OFF WHEN USED IN CT. I DO NOT HAVE THE LOT NUMBER. MISSION HAS A SAMPLE AND I HAVE A PICTURE THAT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20166477 ↗
• MalfunctionAug 7, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO MULTI FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: EMAIL VERBATIM: ¿DURING HARSH INFUSION TEST, TWO SAMPLES WERE IDENTIFIED LEAKING ON JULY 9. AND THESE TWO SAMPLES WERE RE-TEST LATE ON JULY 23, ONLY ONE FOUND LEAK. THE FAILED SAMPLE WILL BE USED FOR ROOT CAUSE ANALYSIS. THE LEAK LOCATES ON UPPER SEAL OF THE SEPTUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927343 ↗
• MalfunctionJul 29, 2024Defective Component; Defective Component

  CORRECTION IT WAS REPORTED THAT BD MAXZERO MULTI FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DAMAGED. WHEN ATTEMPTING TO PLACE THE T-PORT ONTO THE IV CATHETER, THE CLEAR ROTATING PIECE THAT ATTACHES THE TWO TOGETHER, IS COMING COMPLETELY OFF OF THE T-PORT. THE PIECE IS NO LONGER ATTACHED TO THE PORT IN ANY WAY AND CANNOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19855122 ↗
• MalfunctionJun 23, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 92 OF THE MICROBORE EXTENSION SET, IV CONNECTOR, T EXPERIENCED PRINT PERMANENCY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE 92 CA OF ALMZXT9001 WERE MIXED IN MULTIPLE LOTS, BECAUSE THE LOT # AND EXPIRY DATE PRINTED ON THE PRODUCT ARE TOO SMALL AND TOO LIGHT TO BE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192191 ↗
• MalfunctionSep 2, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE MICROBORE EXTENSION SET, IV CONNECTOR, T CAME LOOSE FROM THE MAXZERO TUBING DURING USE AND LEAKED CONTRAST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SO WHAT IS HAPPENING IS THE MAXZERO TUBING THAT IS ALREADY ON THE PATIENT IS BEING CONNECTED TO THE CONTRAST TUBING AND THEN STARTS THE PROCESS FOR THE CONTRAST WHICH IS THEN AT TIMES THE CONNECTION COMES LOOSE AND CONTRAST LEAKS OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413948 ↗
• MalfunctionJul 7, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT MICROBORE EXTENSION SET, IV CONNECTOR, T LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MZXT9001 BATCH NO (LOT NO): UNKNOWN. IT WAS REPORTED LEAKING NOTED FROM THE WHITE HUB. " LEAKING NOTED FROM THE WHITE HUB ON THE PIV T-CONNECTOR. STAFF DID CLEAN UP LEAK AND NOTED THAT IT DID CONTINUE. EXTENSION REPLACED. STAFF REPORTED THIS IS THE SECOND T-CONNECTOR EXTENSION THAT LEAKED THIS WEEK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10241964 ↗
• MalfunctionDec 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT T-CONNECTORS LEAKED TWICE FROM THE DISTAL VALVE. THIS RESULTED IN A DELAY IN CARE AS A "DIFFERENT MEANS TO INJECT" HAD TO BE UTILIZED. IT WAS FURTHER CONFIRMED DURING FOLLOW UP, THAT THERE WAS NO PATIENT HARM OR IMPACT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9466817 ↗
• MalfunctionDec 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT T-CONNECTORS LEAKED TWICE FROM THE DISTAL VALVE. THIS RESULTED IN A DELAY IN CARE AS A "DIFFERENT MEANS TO INJECT" HAD TO BE UTILIZED. IT WAS FURTHER CONFIRMED DURING FOLLOW UP, THAT THERE WAS NO PATIENT HARM OR IMPACT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9466769 ↗
• MalfunctionNov 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN (NICU) RN NOTICED THAT THE GAUZE ON THE BABY'S (PIV) SITE WAS WET SOON AFTER THE GENTAMICIN SYRINGE (2ML) INFUSION WAS STARTED. UPON FLUSHING THE MEDICATION BD 3 ML MATED TO THE MAX ZERO EXTENSION SET 152 CM, THE USER OBSERVED A LEAK FROM THE MAX ZERO EXTENSION SET (15CM) AT THE POINT WHERE THE WHITE PLASTIC AND CLEAR PLASTIC MEET. THE USER TIGHTENED THE CONNECTION, HOWEVER; IT CONTINUED TO LEAK WITH FLUSHING AT THE SPIN MALE LUER LOCK. THE USER REMOVED THE SET AND CONTINUED IV FLUIDS THRU THE (PIV). IT WAS FURTHER CONFIRMED DURING FOLLOW UP, THAT THERE WAS NO PATIENT HARM NOR IMPACT AS A RESULT OF THIS EVENT. (THE FACILITY BEGAN USING MZ9267 HOUSE WIDE APPROXIMATELY 1 MONTH. THE SET WAS MATED TO (2 ML) SYRINGE IT IS CONNECTED TO THE EXTENSION TUBING (152 CM) WHICH IS THEN CONNECTED TO THE T -CONNECTOR (15CM) WHICH IS CONNECTED TO THE IV CATHETER).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9324644 ↗
• MalfunctionFeb 28, 2019Component Missing; Obstruction of Flow; Component Missing; Obstruction of Flow

  RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH WHICH STATES, "PATIENT IN LONG-TERM CARE FACILITY. RN WENT TO FLUSH PATIENT'S PERIPHERAL IV IN LEFT FOREARM AND LINE WAS OCCLUDED. ON INVESTIGATION IT WAS NOTED THAT THE WHITE PORT ON THE T CONNECTOR WAS MISSING THE BLUE DIAPHRAGM PIECE. LINE WAS PLACED ON (B)(6) 2018 AND OCCLUDED ON (B)(6) 2018." THE PRODUCT WAS REPLACED, AND THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8380625 ↗
• MalfunctionSep 6, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED FLUID LEAKED FROM THE T-CONNECTOR EXTENSION SET WHEN ATTACHED TO THE PATIENT'S PICC LINE AND FLUSHED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7852896 ↗
• MalfunctionAug 2, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT BLOOD BACKED UP INTO THE LINE AND SALINE LEAKED FROM THE EXTENSION SET WHEN IT WAS CONNECTED TO THE IV SITE. THE SET WAS REMOVED AND REPLACED WITH A NEW T-CONNECTOR. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7742821 ↗