MaxGuard MX4439Recalls & reported problems
BD Switzerland Sàrl · Extension set, with 2 needleless Y-site and 4-way stopcock 102 cm (40 in) · Class 2
Quick summary
This BD MaxGuard extension set is an IV line with two needleless Y-sites and a four-way stopcock, used to administer fluids and drugs. The 54 reports mostly describe the tubing breaking or leaking at the lock when nurses reattach it, along with cracked components and fluid or blood leaking out. No deaths and no injuries are reported. No recalls name this device, and reporting has stayed level.
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
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10885403237485), received between Feb 7, 2019 and Feb 20, 2026 — classified as 54 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (16 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 Leak16
- Break13
- Leak/Splash13
- Defective Component9
- Material Separation2
- Separation Problem2
- Air/Gas in Device1
- Complete Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- No Information10
- No Consequences Or Impact To Patient6
- Insufficient Information5
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Crack; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24407785 ↗MalfunctionDec 30, 2025Break; Break
IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BRECK BROKEN IV TUBING I HAVE ATTACHED A PICTURE, BUT WE HAVE HAD 4-5 THIS WEEK WHERE THE NURSE WHEN TO REATTACH AND THE LOCK BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919427 ↗MalfunctionDec 30, 2025Break; Break
IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BRECK BROKEN IV TUBING I HAVE ATTACHED A PICTURE, BUT WE HAVE HAD 4-5 THIS WEEK WHERE THE NURSE WHEN TO REATTACH AND THE LOCK BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919423 ↗MalfunctionDec 30, 2025Break; Break
IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BRECK BROKEN IV TUBING I HAVE ATTACHED A PICTURE, BUT WE HAVE HAD 4-5 THIS WEEK WHERE THE NURSE WHEN TO REATTACH AND THE LOCK BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919421 ↗MalfunctionDec 29, 2025Break; Break
IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BRECK BROKEN IV TUBING I HAVE ATTACHED A PICTURE, BUT WE HAVE HAD 4-5 THIS WEEK WHERE THE NURSE WHEN TO REATTACH AND THE LOCK BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919355 ↗MalfunctionDec 29, 2025Break; Break
IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BRECK BROKEN IV TUBING I HAVE ATTACHED A PICTURE, BUT WE HAVE HAD 4-5 THIS WEEK WHERE THE NURSE WHEN TO REATTACH AND THE LOCK BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919311 ↗MalfunctionDec 29, 2025Break; Break
IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BRECK BROKEN IV TUBING I HAVE ATTACHED A PICTURE, BUT WE HAVE HAD 4-5 THIS WEEK WHERE THE NURSE WHEN TO REATTACH AND THE LOCK BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919281 ↗MalfunctionDec 29, 2025Break; Break
IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BRECK BROKEN IV TUBING I HAVE ATTACHED A PICTURE, BUT WE HAVE HAD 4-5 THIS WEEK WHERE THE NURSE WHEN TO REATTACH AND THE LOCK BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919276 ↗MalfunctionDec 17, 2025Break; Break
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT HAVE HAD 4-5 THIS WEEK WHERE THE NURSE WHEN TO REATTACH AND THE LOCK BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835156 ↗MalfunctionNov 18, 2025Separation Problem; Separation Problem
IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET HAD SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE BEEN HAVING ISSUES AGAIN WITH THE EXTENSION SET TUBING BREAKING. I HAVE INCLUDED THE LOT NUMBER AND A PICTURE OF THE BROKEN TUBING. PRODUCT CODE# MX4439. LOT# 25075353.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23586968 ↗MalfunctionOct 19, 2025Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY A CUSTOMER THAT THE CAPS OPEN IT UP TO AIR AND NEED TO HAVE CAPS THAT ARE CLOSED OFF TO AIR AND THEY REQUIRE A 3-MANIFOLD FOUR-WAY STOPCOCK EXTENSION SET THAT WILL ATTACH TO THE BLOODSET FOR INDUCTION MEDICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333626 ↗MalfunctionOct 19, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBARIM. IT WAS REPORTED BY A CUSTOMER THAT THE CAPS OPEN IT UP TO AIR AND NEED TO HAVE CAPS THAT ARE CLOSED OFF TO AIR AND THEY REQUIRE A 3-MANIFOLD FOUR-WAY STOPCOCK EXTENSION SET THAT WILL ATTACH TO THE BLOODSET FOR INDUCTION MEDICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333625 ↗MalfunctionAug 24, 2025Defective Component; Defective Component
IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET HAD DEFECTIVE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REF# (B)(4) DID NOT WORK AS THE PROVIDERS HAS TO CONNECT MULTIPLE STOPCOCKS TO MAKE IT MEET TO THE ORIGINAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22881430 ↗MalfunctionAug 24, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REF# MX4439 HAD LOTS OF LEAKING ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22881424 ↗MalfunctionJul 15, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE Y SET AT THE STOP COCK IT CRACKS AND LEAKS OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22507102 ↗MalfunctionJan 3, 2025Material Separation; Separation Problem; Material Separation; Separation Problem
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21071285 ↗MalfunctionDec 29, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SE T WITH NEEDLELESS Y-SITE(S) AND STOPCOCK WAS DIFFICULT TO DISCONNECT THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY CAN GET THE LUER LOCK RING TO SPIN FREELY BUT THE STOPCOCK IS NOT COMING LOOSE.
Patient problems: Insufficient Information
MAUDE report 21032671 ↗MalfunctionDec 9, 2024Break; Break
MATERIAL # MX4439. BATCH # 24069065. IT WAS REPORTED BY CUSTOMER THAT STOP-COCK WITH PROPOFOL IN LUMEN BUT LOCKED AND CONNECTED TO PATIENT AS LACTATED RINGER'S GRAVITY INFUSION NUMBER OF DROPS (GTT). LOCKED THE GTT WITH ROLLER CLAMP AND DISTAL CLAMP NEAR IV. REMOVED THE STOPCOCK AND NOTICED THAT THE PLASTIC LUER-LOCK INSIDE THE LUMEN SHEARED OFF. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. STOP-COCK WITH PROPOFOL IN LUMEN BUT LOCKED AND CONNECTED TO PATIENT AS LACTATED RINGER'S GRAVITY INFUSION NUMBER OF DROPS (GTT). LOCKED THE GTT WITH ROLLER CLAMP AND DISTAL CLAMP NEAR IV. REMOVED THE STOPCOCK AND NOTICED THAT THE PLASTIC LUER-LOCK INSIDE THE LUMEN SHEARED OFF. PRODUCT NUMBER - MX4439. LOT NUMBER - 24069065.
Patient problems: Insufficient Information
MAUDE report 20878102 ↗MalfunctionNov 6, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20621632 ↗MalfunctionNov 6, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20621088 ↗MalfunctionOct 9, 2024Break; Break
MATERIAL #: MX4439 BATCH #: UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT TUBING BREAKING AT CONNECTION POINT NEAR THE STOPCOCK VERBATIM: TUBING BREAKING AT CONNECTION POINT NEAR THE STOPCOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20406488 ↗MalfunctionAug 22, 2024Material Separation; Material Separation
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20032361 ↗MalfunctionMay 21, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SE T WITH NEEDLELESS Y-SITE(S) AND STOPCOCK WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. BOTH ENDS OF SKU HAVE BEEN FAULTY. FOLLOW-UP: CUSTOMER RESPONSE ON MAY 03, 2024 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? THIS IS A DESCRIPTION FROM THE ATTENDING SURGEON: ROUGHLY THREE WEEKS AGO I NOTED THAT THE STOPCOCK EXTENSION TUBING WOULD BREAK WITH MINIMAL CONTACT AT THE JOINT BETWEEN THE STOPCOCK AND ITS INCLUDING TUBING. THIS FAILURE REQUIRED DISCONNECT THE TUBING FROM THE ANGIOCATHETER AND REATTACHED NEW TUBING. THIS MANIPULATION IS ALWAYS RISKY AND COULD LIKE TO LOSING THE ANGIOCATHETER ENTIRELY. ON 4/25/2024 WE HAD TO BRING BACK A 9YO PATIENT FROM THE RECOVERY ROOM AFTER A TONSILLECTOMY FOR A BLEEDING TONSILLAR BED. SHE ARRIVED IN THE OR WITH THE ORIGINAL IV AND TUBING FOR THE INITIAL CASE. UPON TRANSFER FROM THE GURNEY TO THE OR BED THE TUBING WAS UNDER HER BLANKET. GENTLY UNDERCOVERING THIS TUBING WAS ENOUGH TORQUE TO CREATE THE SAME FAILURE OF THE STOPCOCK ASSEMBLY I HAD SEEN IN TWO OTHER PATIENT THIS SA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19356562 ↗MalfunctionMay 21, 2024Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19356560 ↗MalfunctionMay 21, 2024Defective Component; Defective Component
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19356559 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.