MaxZero MZ9267Recalls & reported problems
BD Switzerland Sàrl · Microbore extension set, IV connector 152 cm (60 in) · Class 2
Quick summary
This BD MaxZero microbore extension set is a long IV line with a connector, used to administer fluids and blood vessels. Most of the 59 reports describe leaking fluid or blood at or near the patient end, along with cracks and breaks in the tubing, occasional complete blockage, and connectors that get stuck or come apart. Reports mention no deaths and one injury, and 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
- 60
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10885403240720), received between Jul 11, 2018 and Sep 30, 2026 — classified as 1 injury, 59 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (28 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
- Fluid/Blood Leak28
- Leak/Splash10
- Complete Blockage5
- Break4
- Defective Component4
- Connection Problem2
- Loose or Intermittent Connection2
- Separation Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient20
- No Known Impact Or Consequence To Patient10
- No Information6
- Blood Loss1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
The collar on MaxZero Microbore extension set syringe tubing broke off necessitating IV tubing set replacement. No harm to patient. Broken set discarded at time of event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945377 ↗MalfunctionSep 4, 2026Break
Patient problems: Insufficient Information
MAUDE report 50622816 ↗MalfunctionMar 13, 2026Connection Problem
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET HAD CONNECTION ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT MALE PIECE OF EXTENSION SET IS GETTING STUCK IN AN ICU MEDICAL CAP AND CAUSING AN UNBREAKABLE CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24591061 ↗MalfunctionFeb 24, 2026Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434238 ↗MalfunctionFeb 24, 2026Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434237 ↗MalfunctionFeb 9, 2026Complete Blockage
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293022 ↗MalfunctionFeb 2, 2026Complete Blockage
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24239973 ↗MalfunctionJan 27, 2026Break
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24192753 ↗MalfunctionNov 11, 2025Leak/Splash; Leak/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 A CUSTOMER THAT THE TUBING LEAKING AT THE SITE NEAR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23528799 ↗MalfunctionNov 7, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THEY ARE UNABLE TO PUSH ANYTHING THRU TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497739 ↗MalfunctionOct 23, 2025Defective Component; Obstruction of Flow; Defective Component; Obstruction of Flow
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 CUSTOMER THAT UNABLE TO FLUSH 0.6ML IV EXTENSION TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23373334 ↗MalfunctionSep 14, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE EXTENSION SET IS NOT PRIMING. THE NURSE WILL ATTACH A SALINE FLUSH TO MANUALLY PRIME, AND THEY PRESS AS HARD AS THEY CAN ON THE SYRINGE, BUT SALINE WILL NOT FLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23047850 ↗MalfunctionSep 9, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE TUBING IS VERY DIFFICULT TO DISCONNECT FROM THE IV HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22999964 ↗MalfunctionSep 3, 2025Failure to Disconnect; Failure to Disconnect
IT WAS REPORTED THAT THE BD MAXZERO MICROBORE EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD MAXZERO MICROBORE EXTENSION SET IV CONNECTOR TUBING # MZ9267 IS VERY DIFFICULT TO DISCONNECT FROM THE NEEDLEFREE CONNECTOR IT'S BEING ATTACHED TO. THE MALE CONNECTOR IS STUCK IN THE MICROCLAVE OF THE PIV EXTENSION SET. THE NURSES HAVE BEEN USING HEMOSTATS TO DISCONNECT THE IV TUBING FROM THE PATIENT IV. IN SOME CASES THIS ISSUE CAUSED THE CLAVE TO NO LONGER BE ANTI-REFLUX AND THE PT HAD BLOOD COMING OUT OF THE LINE. THIS HAS BEEN REPORTED ON MULTIPLE UNITS. CUSTOMER USES 50,000+ EACH PER YEAR AND THIS HAS ONLY JUST BECOME AN ISSUE THE PAST COUPLE OF WEEKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956943 ↗MalfunctionJun 2, 2025Component Missing; Separation Failure; Component Missing; Separation Failure
IT WAS REPORTED THAT BD MAXZERO MICROBORE EXTENSION SET WAS MISSING A COMPONENT THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE TWISTING PART OF THE LUER HAS COME OFF, INCLUDING 1 WHERE THEN THE END OF THE TUBING GOT STUCK IN THE VALVE AND BROKE OFF THE TUBING, REQUIRING THEM TO GET A CLAMP TO PULL IT OUT AND THE PIECE THAT BROKE OFF IS THE DISTAL END LUER LOCK PIECE THAT CONNECTS TO THE PATIENT TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22127001 ↗MalfunctionMay 29, 2025Leak/Splash; Separation Failure; Leak/Splash; Separation Failure
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22109859 ↗MalfunctionFeb 3, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21295023 ↗MalfunctionJan 18, 2024Defective Component; Defective Component
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18536086 ↗MalfunctionAug 11, 2023Complete Blockage; Failure to Prime; Complete Blockage; Failure to Prime
IT WAS REPORTED THAT 2 BD MAXZERO¿ MULTI-FUSE EXTENSION SETS WITH NEEDLELESS CONNECTOR WERE BLOCKED WHILE ATTEMPTING TO PRIME THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE HAVING ISSUES WITH PART NUMBER 20029E, THE MICRON FILTER IS LEAKING AND THIS A HUGE SAFETY CONCERN BECAUSE A CRITICAL MED WAS LEAKING. THIS HAS BEEN HAPPENING ABOUT 3-4 TIMES NOW IN THE PAST WEEK OR SO... - ARE YOU ABLE TO PROVIDE EVENT DATE? NICU: I BELIEVE THE NURSE WROTE THE DATE ON THE PRODUCTS THAT WOULD NOT FLUSH. - CAN YOU IDENTIFY THE BATCH NUMBER? LOT # 23059265 - IS THERE ANY ADVERSE EVENT OCCURRED? NICU: NO - AS REPORTED, THERE WAS A SAFETY ISSUE HAPPENED, CAN YOU PROVIDE DETAILS? NICU: NURSE REPORTED THAT SHE WAS NOT ABLE TO PRIME TWO TUBINGS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17515925 ↗MalfunctionJul 17, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD MAXZERO¿ EXTENSION SET, MICROBORE, MAXZERO¿ NEEDLE-FREE CONNECTOR LEAKAGE OCCURRS. THIS IS THE 1ST OF 2 EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSES HAVE TOLD BE ABOUT THE FOLLOWING ISSUES A FEW TIMES NOW: BOTH MAX ZERO MZ9267 AND THE TUBING WITH THE PRESSURE SENSING DEVICE THAT HAVE A 1.2MICRON FILTER ATTACHED THAT SEEM TO BE LEAKING WHERE THE FILTER CONNECTS TO THE TUBING, AND OCCASIONALLY WHERE THE VALVE IS CONNECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17339310 ↗MalfunctionJul 17, 2023Defective Component; Defective Component
IT WAS REPORTED THAT DURING USE WITH BD MAXZERO¿ EXTENSION SET, MICROBORE, MAXZERO¿ NEEDLE-FREE CONNECTOR THE TUBING WAS DAMAGED. THIS IS THE 2ND OF 2 EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I ALSO HAVE HAD NURSE SAY THE PRESSURE SENSING DEVICE TUBING HAS ¿EXPLODED¿ AT ONE OF OUR SATELLITE UNITS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17339307 ↗MalfunctionMay 10, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 1 BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR EACH FROM LOTS 21125635, 21115715, 21055457, AND 21105940, AS WELL AS FOUR SEPARATE, UNSPECIFIED LOTS, HAD ISSUES WITH LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS JUST DISCUSSED, BECAUSE OUR CRITICAL CARE AREAS HAD CONTINUOUS LEAKING WITH BD SET AND FILTER MZ9267 AND 10011865, THAT RESULTED IN PRODUCT BEING PULLED FROM THOSE AREAS"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14349779 ↗MalfunctionMar 22, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED WHEN USING THE BD MAXZERO MICROBORE EXTENSION SET, THE DEVICE EXPERIENCED A LINE OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT A LINE OCCLUSION ALARM IS TRIGGERED WHEN APPROXIMATELY 40ML OF MEDICATION OR WATER IS INFUSED OVER FIVE MINUTES. IT WAS REPORTED THAT IN THE EMERGENCY DEPARTMENT, THE SYRINGE MODULE ALARMS WHEN USING THE MAXZERO MZ9267 EXTENSION SET. A ¿LINE OCCLUSION¿ ALARM IS TRIGGERED WHEN APPROXIMATELY 40ML OF MEDICATION OR WATER IS INFUSED OVER FIVE MINUTES. IF THE INFUSION RATE IS SLOWED DOWN, THERE IS NO LONGER AN ALARM. THE INFORMATION ON PATIENT INVOLVEMENT IS UNKNOWN. ADDITIONALLY, THE HOSPITAL PERFORMED TESTING ON A DIFFERENT PC AND SYRINGE MODULE WITH A BD 50 ML SYRINGE WITH WATER, CONNECTED AND PRIMED WITH A BD MAXZERO EXTENSION SET. THE SYRINGE PUMP OCCLUSION PRESSURE LIMIT WAS SET TO "HIGH." AND MULTIPLE TESTS WERE PERFORMED USING BASIC INFUSION WITH INFUSION RATES OF 504 ML/HOUR, 480 ML/HOUR AND 400 ML/HOUR. THE OCCLUSION ALARM WENT OFF INDICATING OCCLUSION AT PATIENT SIDE AT 504 ML/HOUR AND AT 480 ML/HOUR. THERE WAS NO ALARM AT 400 ML/HOUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13848340 ↗MalfunctionJan 31, 2022Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component
IT WAS REPORTED WHEN USING THE BD MICROBORE EXTENSION SET, IV CONNECTOR, THE DEVICE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT THE MAXZERO NEEDLELESS CONNECTOR IS LEAKING. HAVE YOU HEARD OF ISSUES WITH THE MEDICATION LINE (MZ9267) AND LEAKING? THE STAFF HAVE REPORTED LEAKING AT THE SITE OF THE MAXZERO NEEDLELESS CONNECTOR. HAS ANYONE ELSE BEEN HAVING THIS PROBLEM?
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13404764 ↗MalfunctionJun 17, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE MICROBORE EXTENSION SET, IV CONNECTOR LEAKED AT THE END OF THE GENTAMICIN INFUSION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ENCOUNTERED A LEAK WHILE USING BD 3 ML LUER LOK SYRINGE (REF 309657) WHEN ATTACHED TO THE BD MAXZERO MICROBORE EXTENSION SET TUBING (REF MZ9267). GENTAMICIN 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."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12019159 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.