MaxZero MZ5307Recalls & reported problems

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 10885403230608), received between Jul 11, 2018 and Aug 16, 2026 — classified as 11 injuries, 123 malfunctions.

The most frequently reported specific device problem is “Break” (55 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 134 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2026Backflow

  It was reported that BD maxzero extension set had flow issues.The following information was received by the initial reporter with the following Verbatim.It was reported by the customer that found blood backed up to the IV filter during rounds.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268474 ↗
• MalfunctionMay 31, 2026Complete Blockage

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE TUBING STRUNG WITH A BIFUSE FOR PICC. ONCE HUNG, INFUSION PUMP BEGAN ALARMING OCCLUDED FOR BOTH THE MAINLINE AND THE MEDLINE PORTS. NOTHING CLAMPED OR KINKED FOUND. UNABLE TO FLUSH THRU MEDLINE. TRIED RESEATING CONNECTIONS. OCCLUSION CONTINUED. ENDED UP SWITCHING OUT BIFUSE TUBING AND THEN ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25341056 ↗
• MalfunctionMay 21, 2026Complete Blockage

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT PUMP ALARMING OCCLUSION WHEN USING THE BD MAXZERO BIFUSE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247715 ↗
• MalfunctionMay 7, 2026

  LOOKS LIKE A MANUFACTURER ERROR. TUBING IS CUT ON THE PATIENT CONNECTOR SIDE. DOES NOT HAVE A CONNECTOR PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111070 ↗
• MalfunctionApr 27, 2026Leak/Splash; Separation Problem

  IT IS REPORTED, THE ACTUAL PLASTIC SEPARATED AND THE LUMEN WAS OPEN AND EXPOSED. ADDITIONAL INFORMATION: DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO, IT "BLEW OPEN" AFTER FLUSHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002580 ↗
• MalfunctionApr 22, 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 THE CUSTOMER THAT THERE WAS AN ADDITIONAL STAND ALONE PRODUCT INCLUDED THAT REQUIRES A COMPLAINT: REF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956998 ↗
• MalfunctionNov 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE EMERGENCY DEPARTMENT HAS REPORTED THE FOLLOWING INCIDENT REGARDING ITEM CODE 1032058, 18 CM PRESSURE RESISTOR EXTENSION CORD, MZ5307 (WITHOUT PACKAGING, 1 UNIT): "IT HAS A LEAK IN THE AREA WHERE THE ANTI-REFLUX CAP IS LOCATED." SINCE THIS PROBLEM IS NOT ASSOCIATED WITH A SPECIFIC BATCH AND HAS OCCURRED SEVERAL TIMES, WE RECOMMEND EXPLORING THE POSSIBILITY OF OBTAINING A SAFER AND MORE RELIABLE ALTERNATIVE ON THE MARKET. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: 1) THE LOT NUMBER OF THE VENOUS EXTENDER IS 25029025. 2) THIS INCIDENT HAS OCCURRED MORE THAN 10 TIMES, RESULTING IN LEAKAGE OF ADMINISTERED MEDICATIONS. 3) DURING TODAY, 3/11/2025, THIS PROBLEM HAS OCCURRED 3 TIMES ONLY TODAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23627924 ↗
• MalfunctionJan 31, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER: SITUATION/BACKGROUND: LINES ARE BEING PRIMED AND HUNG ON PATIENTS WITH CENTRAL LINES PER UNIT PROTOCOL. THERE HAVE BEEN FOUR INSTANCES THAT AIR HAS BEEN FOUND IN THE LINE AFTER IT HAS BEEN RUNNING. ONE BABY DECOMPENSATED IMMEDIATELY AND NEEDED RESUSCITATIVE MEASURES AND 24 HOURS LATER WENT TO EMERGENCY SURGERY DUE TO NEC FROM LACK OF BLOOD FLOW (AIR) GETTING TO BABY. ONE BABY HAD PERFUSION CHANGES ON HALF SIDE OF ITS BODY AND RECOVERED. TWO OTHER BABIES THE AIR WAS CAUGHT BEFORE IT REACHED THE PATIENT. WHEN THE BABY IS IN A SWING THAT IS ON THE GROUND, THE FILTER STAYS WITH THE BABY, BUT THIS IS TYPICALLY WHEN WE ARE GETTING AIR IN LINES. OUR PROCESS LOOKS NORMAL FOR WHAT WE'VE ALWAYS DONE AND BEEN EDUCATED; BUT WHAT ELSE WOULD BE CAUSING THE AIR IN THE LINE BASED ON THE INFANT'S LOCATION RELATIVE TO PUMPS SINCE THE FILTER IS REMAINING WITH HER????

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619485 ↗
• MalfunctionJan 31, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET STERILITY IS COMPROMISED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM; DESCRIBE CUSTOMER CONCERN, DETAILS OF EVENT INCLUDING HOW THE ISSUE WAS RESOLVED: THIS IS PACKAGING DESIGN VERIFICATION FAILURE. PACKAGING OQ FAILURE. IF PRODUCT MADE BY THE OQ PARAMETER SETTING, IT MAY HAVE STERILITY BREACH FOR PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619483 ↗
• MalfunctionJan 25, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER:. SITUATION/BACKGROUND: LINES ARE BEING PRIMED AND HUNG ON PATIENTS WITH CENTRAL LINES PER UNIT PROTOCOL. THERE HAVE BEEN FOUR INSTANCES THAT AIR HAS BEEN FOUND IN THE LINE AFTER IT HAS BEEN RUNNING. ONE BABY DECOMPENSATED IMMEDIATELY AND NEEDED RESUSCITATIVE MEASURES AND 24 HOURS LATER WENT TO EMERGENCY SURGERY DUE TO NEC FROM LACK OF BLOOD FLOW (AIR) GETTING TO BABY. ONE BABY HAD PERFUSION CHANGES ON HALF SIDE OF ITS BODY AND RECOVERED. TWO OTHER BABIES THE AIR WAS CAUGHT BEFORE IT REACHED THE PATIENT. WHEN THE BABY IS IN A SWING THAT IS ON THE GROUND, THE FILTER STAYS WITH THE BABY, BUT THIS IS TYPICALLY WHEN WE ARE GETTING AIR IN LINES. OUR PROCESS LOOKS NORMAL FOR WHAT WE'VE ALWAYS DONE AND BEEN EDUCATED; BUT WHAT ELSE WOULD BE CAUSING THE AIR IN THE LINE BASED ON THE INFANT'S LOCATION RELATIVE TO PUMPS SINCE THE FILTER IS REMAINING WITH HER? ASSESSMENT: AFTER THOROUGH INVESTIGATION OF THE PRODUCTS AND HOW LINES ARE HANGING, THE BEST GUESS IS IT IS THE MAX ZERO MINIBORE BI-FUSE PRESSURE RATED EXTENSION SET (REF MZ 5307). IF THE MED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18584313 ↗
• InjuryJan 25, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET CAUSED AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER: SITUATION/BACKGROUND: LINES ARE BEING PRIMED AND HUNG ON PATIENTS WITH CENTRAL LINES PER UNIT PROTOCOL. THERE HAVE BEEN FOUR INSTANCES THAT AIR HAS BEEN FOUND IN THE LINE AFTER IT HAS BEEN RUNNING. ONE BABY DECOMPENSATED IMMEDIATELY AND NEEDED RESUSCITATIVE MEASURES AND 24 HOURS LATER WENT TO EMERGENCY SURGERY DUE TO NEC FROM LACK OF BLOOD FLOW (AIR) GETTING TO BABY. ONE BABY HAD PERFUSION CHANGES ON HALF SIDE OF ITS BODY AND RECOVERED. TWO OTHER BABIES THE AIR WAS CAUGHT BEFORE IT REACHED THE PATIENT. WHEN THE BABY IS IN A SWING THAT IS ON THE GROUND, THE FILTER STAYS WITH THE BABY, BUT THIS IS TYPICALLY WHEN WE ARE GETTING AIR IN LINES. OUR PROCESS LOOKS NORMAL FOR WHAT WE'VE ALWAYS DONE AND BEEN EDUCATED; BUT WHAT ELSE WOULD BE CAUSING THE AIR IN THE LINE BASED ON THE INFANT'S LOCATION RELATIVE TO PUMPS SINCE THE FILTER IS REMAINING WITH HER? ASSESSMENT: AFTER THOROUGH INVESTIGATION OF THE PRODUCTS AND HOW LINES ARE HANGING, THE BEST GUESS IS IT IS THE MAX ZERO MINIBORE BI-FUSE PRESSURE RATED EXTENSION SET (REF MZ 5307). IF T

  Patient problems: Hypoxia

  MAUDE report 18583849 ↗
• InjuryJan 25, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET CAUSED AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. SITUATION/BACKGROUND: LINES ARE BEING PRIMED AND HUNG ON PATIENTS WITH CENTRAL LINES PER UNIT PROTOCOL. THERE HAVE BEEN FOUR INSTANCES THAT AIR HAS BEEN FOUND IN THE LINE AFTER IT HAS BEEN RUNNING. ONE BABY DECOMPENSATED IMMEDIATELY AND NEEDED RESUSCITATIVE MEASURES AND 24 HOURS LATER WENT TO EMERGENCY SURGERY DUE TO NEC FROM LACK OF BLOOD FLOW (AIR) GETTING TO BABY. ONE BABY HAD PERFUSION CHANGES ON HALF SIDE OF ITS BODY AND RECOVERED. TWO OTHER BABIES THE AIR WAS CAUGHT BEFORE IT REACHED THE PATIENT. WHEN THE BABY IS IN A SWING THAT IS ON THE GROUND, THE FILTER STAYS WITH THE BABY, BUT THIS IS TYPICALLY WHEN WE ARE GETTING AIR IN LINES. OUR PROCESS LOOKS NORMAL FOR WHAT WE'VE ALWAYS DONE AND BEEN EDUCATED; BUT WHAT ELSE WOULD BE CAUSING THE AIR IN THE LINE BASED ON THE INFANT'S LOCATION RELATIVE TO PUMPS SINCE THE FILTER IS REMAINING WITH HER? ASSESSMENT: AFTER THOROUGH INVESTIGATION OF THE PRODUCTS AND HOW LINES ARE HANGING, THE BEST GUESS IS IT IS THE MAX ZERO MINIBORE BI-FUSE PRESSURE RAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18582740 ↗
• MalfunctionDec 18, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18350984 ↗
• MalfunctionJan 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED WHILE USING BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S) THE DEVICE WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I JUST HAPPENED TO FIND THIS DEFECTIVE BIFUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16209718 ↗
• MalfunctionJun 10, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE UNSPECIFIED BD MAXZERO EXTENSION SET EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS BLOOD REFLUX AFTER THE ADMINISTRATION OF DRUGS BY SIMPLE DESCENT, AND DOUBTS AROSE REGARDING THE CHANGE OF THE NEEDLE-FREE CONNECTORS, WHICH ARE ALREADY INCLUDED IN THE EXTENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14651673 ↗
• MalfunctionMay 7, 2022Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED A CASE OF LEAKAGE, AND AT LEAST ONE CASE OF COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PRODUCT TRAINING, THE NURSE REPORTS THAT WHEN TRANSFERRING A PATIENT FROM THE STRETCHER TO THE BED, THE MAXZERO EXTENSION CORD BECAME ENTANGLED AT THE TIME OF TRANSFER AND BROKE. WITH NO DAMAGE IMPACT TO THE USER, THE DEVICE WAS REPLACED. THE CARE MANAGEMENT TEAM STATES THAT THE EXTENDERS BREAK EASILY AT THE CONNECTION OF THE BIFURCATION TO THE LUMENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14318421 ↗
• MalfunctionSep 20, 2021Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A MINI BORE BI-FUSE HAD THE MAIN TUBING (BEFORE IT SPLITS INTO TWO SMALLER LUMENS) SEPARATE FROM THE DISTAL SEGMENT WHERE IT INSERTS INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12502589 ↗
• MalfunctionJun 23, 2021Break; Break

  IT WAS REPORTED THAT MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR TUBING BECAME DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING BECAME DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055247 ↗
• MalfunctionJun 23, 2021Break; Break

  IT WAS REPORTED THAT MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR TUBING BECAME DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING BECAME DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055246 ↗
• MalfunctionJun 23, 2021Break; Break

  IT WAS REPORTED THAT MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR TUBING BECAME DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING BECAME DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055223 ↗
• MalfunctionJun 23, 2021Break; Break

  IT WAS REPORTED THAT MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR TUBING BECAME DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING BECAME DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055215 ↗
• MalfunctionJun 14, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT 18 MINIBORE BI-FUSE PRESSURE 2 IV CONNECTORS EXPERIENCED DAMAGED OR OPEN UNIT PACKAGING/SEAL WHERE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: MZ5307, BATCH/LOT #: 20126424. PACU TEAM SAID THAT THEY ARE SEEING A DEFECT AROUND THE SEALING OF THE PACKAGE IN PRODUCT #MZ5307. IT LOOKS LIKE THE PLASTIC DIDN¿T ADHERE TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996773 ↗
• MalfunctionMay 20, 2021Backflow; Complete Blockage; Leak/Splash; Backflow; Complete Blockage; Leak/Splash

  IT WAS REPORTED THAT MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR CAME APART, LEAKED, AND HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MZ5307 BATCH NO: UNKNOWN [EVENT 4] IT WAS REPORTED THAT TUBING POPPED AT Y-SITE CAUSING THE LINE TO BLEED BACK AND CLOT OFF. THE ATTEMPT TO ASPIRATE WAS UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853571 ↗
• MalfunctionMay 20, 2021Backflow; Leak/Splash; Backflow; Leak/Splash

  IT WAS REPORTED THAT MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR LEAKED AND HAD BLOOD BACKFLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MZ5307 BATCH NO: UNKNOWN. [EVENT 3] IT WAS REPORTED THAT MEDICATION WAS LEAKING AND BLOOD BACKED UP INTO THE CAP. AND ON THE Y-CONNECTOR INTO THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853570 ↗
• MalfunctionMay 20, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MZ5307, BATCH NO: UNKNOWN. [EVENT 1] IT WAS REPORTED THAT TUBING WAS TUGGED AND BROKE AT THE Y-SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853547 ↗