MaxZero MZ5310Recalls & reported problems
BD Switzerland Sàrl · Pressure rated extension set, removable IV connector, 17.5 cm (7 in) · Class 2
Quick summary
This BD MaxZero pressure-rated extension set is a short IV tubing set with a removable needleless connector used to flush and access lines. The 47 reports mostly describe leaking or splashing at the connector and hub during flushing, blood or saline spraying out, and connections that come loose or disconnect. No deaths or injuries were reported, and no recalls name this device. Reports rose from 12 in the earlier 12-month period to 34 in the most recent one.
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
- 46
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10885403242090), received between Aug 21, 2024 and Sep 24, 2026 — classified as 46 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (17 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/Splash17
- Fluid/Blood Leak8
- Disconnection7
- Loose or Intermittent Connection7
- Activation, Positioning or Separation Problem3
- Break3
- Material Separation3
- Separation Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Separation Problem
It was reported that BD maxzero needless connector was separatedThe following information was received by the initial reporter with the following VerbatimIt was reported by customer that the connector came apart and ,sprayed clinician in face, this happened in CT. This has been an ongoing issue along with CT other departments within the facility also are reporting this.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876674 ↗MalfunctionSep 24, 2026Separation Problem
It was reported that BD maxzero needless connector was separatedThe following information was received by the initial reporter with the following VerbatimIt was reported by customer that the connector came apart and ,sprayed clinician in face, this happened in CT. This has been an ongoing issue along with CT other departments within the facility also are reporting this.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876672 ↗MalfunctionSep 24, 2026Separation Problem
It was reported that BD maxzero needless connector was separatedThe following information was received by the initial reporter with the following VerbatimIt was reported by customer that the connector came apart and ,sprayed clinician in face, this happened in CT. This has been an ongoing issue along with CT other departments within the facility also are reporting this.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876671 ↗MalfunctionAug 16, 2026Leak/Splash
It was reported that BD maxzero needless connector was leaking.The following information was received by the initial reporter with the following Verbatim.It was reported by customer that Pt. came in with the max zero caps on port line - when flushing blood and saline came out of port getting the pt. soaked.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50266281 ↗MalfunctionJul 9, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25774176 ↗MalfunctionJun 16, 2026Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MZ5310 - ROUNDED ON ALL 5 UNITS IN HV HOSPITAL AT REX AND SPOKE WITH ALL NURSES ON FLOORS. AFTER SPEAKING WITH ABOUT 35 NURSES, EACH ONE SHARED THAT IT IS OCCURRING FREQUENTLY THAT PATIENTS WITH NEW IVS OR EXISTING ONES ARE HAVING LEAKING AT THE HUB OF THE IV AT LEAST ONCE IF NOT MORE PER SHIFT. AFTER HAVING TO TAKE OF DRESSING THE SPIN COLLAR IS MALE LUER OF THE EXTENSION SET IS COMPLETELY OFF OR THE SPIN COLLAR IS EXTREMELY LOOSE. 6HV HAS REPORTED SEVERAL WHERE THE SPIN COLLAR IS ALL THE WAY DOWN ON THE EXTENSION TUBING PAST THE RETENTION BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25526691 ↗MalfunctionJun 16, 2026Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6)- SAFE REPORT FROM (B)(6) OF IV LEAKING AT THE HUB, NURSE UNDRESSED THE LINE AND RECONNECTED THE LOOSE SPIN COLLAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25525220 ↗MalfunctionJun 16, 2026Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6)- SAFE REPORT FROM (B)(6) OF IV LEAKING AT THE HUB, NURSE UNDRESSED THE LINE AND RECONNECTED THE LOOSE SPIN COLLAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25524200 ↗MalfunctionJun 15, 2026Fluid/Blood Leak; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD A LOOSE COMPONENT WITH A LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MZ5310 - THIS RN RECEIVED PT FROM EP LAB/PACU. R AC IV BLOODY, UPON TAKING DRESSING OFF RN VISUALIZED THAT THE SPIN COLLAR/HUB OF IV AND EXTENSION WAS COMPLETELY LOOSE. TIGHTENED CONNECTION TO R AC PIV AND REDRESSED/CLEANSED AND IV WORKED WELL AFTER. LATER IN THE EVENING THE L PIV HUB ALSO CAME LOOSE ON ITS OWN AND WAS BLOODY/MESSY, NEEDED TO BE REDRESSED. THIS WAS INFUSING AMIO, WHICH NEEDS SECURE CONNECTIONS. THIS IS A REOCCURRING ISSUE WITH THE NEW BD CONNECTOR/EXTENSIONS. HAPPENS ABOUT ONCE OR TWICE A SHIFT TO MULTIPLE PATIENTS. THE CONNECTION BECOMES LOOSE AT THE HUB OF THE IV CATHETER. THERE IS ALSO A PRESSURE ISSUE WITH THESE WHERE BLOOD STAYS BACKED UP IF NOT IMMEDIATELY CLAMPED. OVERALL, THIS PRODUCT IS GIVING US ISSUES. LOOSE CONNECTION WITH NEW BD SPIN COLLAR/IV EXTENSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25512349 ↗MalfunctionJun 12, 2026Break
IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS BROKE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED THAT THE EXTENSION SET HAD A BROKEN LUER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25490944 ↗MalfunctionApr 22, 2026Complete Blockage
IT IS REPORTED, THE BLUE CLAVES SOMETIMES GET CLOGGED WITH BLOOD OR PROPOFOL WHICH CAUSES THE LINES NOT TO FLOW WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956285 ↗MalfunctionApr 22, 2026Failure to Disconnect
IT IS REPORTED, THE CONNECTIONS ARE VERY DIFFICULT TO GET OFF TO THE POINT IT HAS CAUSED PROVIDERS TO REPLACE LINES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956282 ↗MalfunctionApr 14, 2026Restricted Flow rate
IT IS REPORTED, MAXZERO PRODUCT, FLOW ISSUES- FLOW WAS SLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24875263 ↗MalfunctionMar 4, 2026Disconnection; Leak/Splash
IT¿S COMING UNDONE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24508534 ↗MalfunctionMar 3, 2026Fluid/Blood Leak; Leak/Splash
IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS LOOSE/ LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT THE NEW BD EXTENSION SETS MD5310 THAT REPLACED MD5309. THE HUB IS SCREWED ON INSTEAD OF GLUED, AND WE ARE HAVING ISSUES WITH THEM NOT STAYING TIGHT AND IN SOME CASES, BOLUSES ACTUALLY EXPLODING OFF THE TUBING. WE HAVE ISSUES WITH LEAKING AND HAVE EVEN HAD ISSUES WHERE ANTICOAG MEDS AREN'T GETTING TO THE PATIENT INTRA-PROCEDURALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24499879 ↗MalfunctionFeb 13, 2026Material Separation
WE HAVE BEEN HAVING AN ISSUE WITH THE MZ5310 WITH THE CONNECTOR POPPING OFF.
Patient problems: Insufficient Information
MAUDE report 24332344 ↗MalfunctionFeb 12, 2026Material Separation
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24326344 ↗MalfunctionFeb 10, 2026Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24307462 ↗MalfunctionFeb 10, 2026Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24306401 ↗MalfunctionFeb 9, 2026Leak/Splash
NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24294015 ↗MalfunctionFeb 9, 2026Disconnection
IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT EXTENSION SET IS DISCONNECTING FROM THE IV CATHETER AND CAUSING LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24294006 ↗MalfunctionFeb 6, 2026Fluid/Blood Leak; Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING AT EXTENSION SET AND CONNECTOR. IT LEAKED BLOOD EVERYWHERE. THE CONNECTOR JUST WOULD NOT GET TIGHT ENOUGH TO PREVENT THE LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24275309 ↗MalfunctionFeb 5, 2026Disconnection; Fluid/Blood Leak
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 ON THE EXTENSION SET IT IS LEAKING FROM THE CONNECTION TO THE IV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273091 ↗MalfunctionFeb 2, 2026Fluid/Blood Leak; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24242352 ↗MalfunctionJan 30, 2026Disconnection; Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXTENSION SET BECAME DISCONNECTED FROM IV, CAUSED LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24228922 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.