MaxZero MZ9270Recalls & reported problems
BD Switzerland Sàrl · Microbore tri-fuse extension set, 3 IV connectors, filter, 14.5 cm, (5.5 in) · Class 2
Quick summary
This BD MaxZero extension set has 123 adverse event reports, with no deaths and 3 injuries. Most reports describe leaks, especially from the filter, along with blocked flow and cracked parts. Reports fell from 14 in the previous year to 1 in the latest year. 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
- 123
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 10885403240737), received between Feb 19, 2019 and Dec 11, 2025 — classified as 3 injuries, 120 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (71 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/Splash71
- Complete Blockage15
- Fluid/Blood Leak14
- Defective Component7
- Crack4
- Flushing Problem4
- Separation Problem3
- Difficult to Flush2
Patient problems
- No Clinical Signs, Symptoms or Conditions102
- No Consequences Or Impact To Patient8
- Insufficient Information5
- Hypoglycemia3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Information2
- Hemorrhage/Blood Loss/Bleeding1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 123 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 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 CUSTOMER THAT LEAKING FROM THE FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23780840 ↗MalfunctionAug 13, 2025Obstruction of Flow; Obstruction of Flow
NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22800383 ↗MalfunctionAug 13, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXPERIENCING MORE ISSUES WITH THEIR FILTER SETS (TPN LEAKING).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22800380 ↗MalfunctionApr 23, 2025Leak/Splash; Leak/Splash
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 WE HAVE HAD 3 FILTERS ON AN IMMUNOTHERAPY INFUSION BREAK IN THE LAST COUPLE OF DAYS. THE INFUSION IS PREPARED IN PHARMACY, SO OUR CHEMO CLINICAL PHARMACIST XXXX MAY BE ABLE TO BETTER HELP YOU WITH DETAILS. PRODUCT REFENCE INFORMATION IS LISTED BELOW. WE DO HAVE ONE OF THE FILTERS SAVED. I WILL INSTRUCT THE RNS TO KEEP THE BROKEN FILTERS AND GIVE THEM TO PHARMACY IF IT HAPPENS AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21890963 ↗MalfunctionApr 23, 2025Leak/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 IT WAS REPORTED BY CUSTOMER THAT TRIFUSE FILTER LEAKS WITH TPN INFUSING BY SYRINGE PUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21890699 ↗MalfunctionFeb 23, 2025Leak/Splash; Leak/Splash
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: TRIFURCATED SPIN-LOCK IV EXTENSION SET CRACKED AND LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21442724 ↗MalfunctionFeb 12, 2025Complete Blockage; Complete Blockage
MATERIAL#: MZ9270. BATCH NUMBER#: UNKNOWN. IT WAS REPORTED THAT THE BD MICROBORE TRI-FUSE EXTENSION SET, 3 IV.C HAD FLOW ISSUES - FLUID BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. TWO 0.2-MICRON FILTERS NOTED TO BE LEAKING FROM VENT WHICH MITIGATES INFUSION OF PARTICULATE MATTER - NOT DEFECTIVE. PRODUCT#: MZ9270.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21364320 ↗MalfunctionFeb 6, 2025Leak/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 IT WAS REPORTED BY THE CUSTOMER THAT WAS REPORTED TO HAVE LEAKING FROM THE FILTER LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21324778 ↗MalfunctionFeb 3, 2025Leak/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 IT WAS REPORTED BY THE CUSTOMER THAT HAD 3 MORE INCIDENT SIMILAR TO THIS ISSUE, WHERE TPN FILTER WAS LEAKING LAST WEEKEND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21294729 ↗MalfunctionFeb 3, 2025Leak/Splash; Leak/Splash
MATERIAL#: MZ9270 & BATCH#: 24039216. IT WAS REPORTED BY THE CUSTOMER THAT HAD 3 MORE INCIDENT SIMILAR TO THIS ISSUE, WHERE TPN FILTER WAS LEAKING LAST WEEKEND. VERBATIM: WE HAD 3 MORE INCIDENT SIMILAR TO THIS ISSUE, WHERE TPN FILTER WAS LEAKING LAST WEEKEND. IT IS FROM SAME LOT#24039216. WE DON'T HAVE SAMPLES THIS TIME UNFORTUNATELY. ADDITIONAL INFO RECEIVED ON 2FEB2025. HI, SORRY WHAT DO YOU MEAN BY OCCURRENCE? ON ONE PATIENT THERE WAS BOTH THE LEAKING FOUND ON THE TPN FILTER, AS WELL AS WHEN THEY THEN WERE PRIMING A NEW ONE, IT WAS UNABLE TO FLUSH THROUGH THE TPN FILTER PORT. THEN ON THE SECOND PATIENT, IT WAS FOUND LEAKING AT THE TPN FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21294699 ↗MalfunctionJan 9, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21118346 ↗MalfunctionDec 11, 2024Leak/Splash; Leak/Splash
MATERIAL#: MZ9270, BATCH#: 24039216. IT WAS REPORTED BY THE CUSTOMER THAT WE HAD AN INCIDENT WHERE TPN FILTER WAS LEAKING. VERBATIM: WE HAD AN INCIDENT WHERE TPN FILTER WAS LEAKING. I HAVE SAMPLE AVAILABLE TO SEND IT TO YOU. PLEASE ADVISE NEXT PROCESS. I HAVE CC'D NURSE EDUCATOR TO THIS EMAIL IF YOU HAVE ANY CLINICAL QUESTIONS. ADDITIONAL INFO: 1. THE DEFECT WAS OBSERVED DURING USE ON A PATIENT. 2. NO, BUT NURSE HAD TO BREAK INTO STERILE LANE AND CHANGE PRODUCT, AND A LEAK/OPENING IN LINE COULD INTRODUCE BACTERIA AND POTENTIALLY PUT PATIENT AT RISK FOR A BLOODSTREAM INFECTION. 3. (B)(6) 2024. 5. THERE HAS BEEN LOTS OF ISSUES WITHIN THE PAST YEAR WITH OUR TPN FILTERS, BUT I BELIEVE SINCE THE MOST RECENT PRODUCT CHANGE (B)(6) 2024) - THIS IS THE SECOND OCCURRENCE 6. NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20902320 ↗MalfunctionDec 8, 2024Leak/Splash; Leak/Splash
MATERIAL#: MZ9270 BATCH NUMBER#: UNKNOWN (24069402). IT WAS REPORTED BY CUSTOMER THAT BD MAXZERO MICROBORE TRI-FUSE EXTENSION SET WAS ADDED TO A CENTRAL LINE, NO ISSUES NOTED WHEN PRIMING. HOWEVER, A COUPLE OF HOURS LATER THE SHEET ON THE BED WAS NOTED TO BE DAMP AND UPON FURTHER INSPECTION THE FILTERED LUMEN OF THE TRI-FUSE SET WAS LEAKING. THIS WAS REPLACED WITH A NEW EXTENSION AND THE LEAK WAS CONFIRMED WITH FLUSHING THE FILTERED LUMEN. THIS LEAK WAS WHERE THE PLASTIC FILTER ATTACHES TO THE TUBING ON THE SIDE OF THE FILTER THAT IS PROXIMAL TO THE PATIENT. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT NAME SET EXT MICBOR TRIFUS 3IV 4CLM. MANUFACTURER BD. CATALOG # MZ9270. ITEM # 614617. ISSUE DESCRIPTION BD MAXZERO MICROBORE TRI-FUSE EXTENSION SET WAS ADDED TO A CENTRAL LINE, NO ISSUES NOTED WHEN PRIMING. HOWEVER, A COUPLE OF HOURS LATER THE SHEET ON THE BED WAS NOTED TO BE DAMP AND UPON FURTHER INSPECTION THE FILTERED LUMEN OF THE TRI-FUSE SET WAS LEAKING. THIS WAS REPLACED WITH A NEW EXTENSION AND THE LEAK WAS CONFIRMED WITH FLUSHING THE FILTERED LUMEN. THIS LEAK WAS WHERE THE PLASTIC FILTER ATTACHES TO THE TUBING ON THE SIDE OF THE FILTER THAT IS PROXIMAL TO THE PATIE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20875012 ↗MalfunctionNov 22, 2024Leak/Splash; Leak/Splash
MATERIAL#: MZ9270, BATCH#: 24069402. IT WAS REPORTED BY THE CUSTOMER THAT THE THEY GOT WITH THAT LOT NUMBER HAVE BEEN "LEAKING". VERBATIM: DATE WAS (B)(6) 2024. ONE OCCURRENCE BUT NOW WE HAVE ANOTHER OCCURRENCE ACCORDING TO THE NIGHT SHIFT NURSE COORDINATOR. LOT NUMBER 24069402. THE STAFF CHANGED SEVERAL BD MAXZERO EXTENSION SETS LAST NIGHT. ADDITIONAL INFO: I NEED A LABEL TO SHIP THE NEWEST EFFECTED LOT# BACK TO YOU. KELLY, WILL HAVE TO ANSWER YOU ON THE 2 BELOW QUESTIONS. ADDITIONAL INFO: 1. IS THERE ANY SAMPLE AVAILABLE FROM THIS EVENT (NO) 2. DATE OF EVENT: 10/26/24. 3. IS THERE ANY ADVERSE EVENT? NO ADVERSE EVENT. RN HAD TO CHANGE OUT 3 DIFFERENT TRI-FUSE EXTENSION SETS DUE TO ALL OF THEM LEAKING. NURSE NOTICED THE LEAKING COMING FROM THE SMALL AIR FILTER HOLE ON THE DISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20759482 ↗MalfunctionNov 19, 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. IT WAS REPORTED BY THE CUSTOMER THAT THE LAST (B)(4) CASES THEY GOT WITH THAT LOT NUMBER HAVE BEEN "LEAKING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20724296 ↗MalfunctionOct 30, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20570677 ↗MalfunctionOct 23, 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: BOTH UNITS WERE FOUND TO BE LEAKING AT THE FILTER.
Patient problems: Insufficient Information
MAUDE report 20516721 ↗MalfunctionOct 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. DURING THE INFUSION OF THE FLUIDS, IT WAS THEN NOTED THAT THE FILTER WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20392998 ↗MalfunctionSep 27, 2024Complete 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 CUSTOMER THAT FILTER WOULD NOT FLUSH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20327540 ↗MalfunctionSep 27, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20326508 ↗MalfunctionSep 27, 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: IT WAS REPORTED BY CUSTOMER THAT LEAKING FROM THE FILTER TUBING INTERFACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20326144 ↗MalfunctionSep 27, 2024Leak/Splash; Leak/Splash
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 (B)(6) 2024 DURING INFUSION, STARTED LEAKING FROM THE HOLE ON THE BACK OF THE FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20323663 ↗MalfunctionSep 27, 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: IT WAS REPORTED BY CUSTOMER THAT SIX (6) MAXZERO TRIFUSE EXTENSION SETS ALL LEAKING AT THE FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20319567 ↗MalfunctionSep 27, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component
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 OCCURRED IN JUNE 2024: ONE FILTER LEAKING FROM THE VENT HOLE ON THE BACK OF THE FILTER. 8/2/2024: SECOND FILTER LEAKING FROM THE VENT HOLE ON THE BACK OF THE FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20319560 ↗MalfunctionSep 27, 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 IT WAS REPORTED BY CUSTOMER THAT SIX (6) MAXZERO TRIFUSE EXTENSION SETS ALL LEAKING AT THE FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20318887 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.