MaxGuard MX4452Recalls & reported problems
BD Switzerland Sàrl · 15 Drop administration set, with 3 needless Y-sites and back check valve and two 4-way Stopcocks 354 cm (140 in) · Class 2
Quick summary
This BD MaxGuard administration set is an IV tubing set with Y-sites, a back check valve and stopcocks, used to give fluids and drugs. The 35 reports mostly describe the tubing leaking or splashing, coming apart at connections, and one-way valves not working so blood backs up into the line; some mention missing parts or tubing that would not prime. No deaths or injuries are reported, and no recalls name this device. Reports have dropped sharply, from 31 in the prior 12 months to 2 in the latest 12 months.
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
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10885403274688), received between Nov 9, 2021 and Mar 20, 2026 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (14 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/Splash14
- Disconnection9
- Complete Blockage2
- Defective Component2
- Material Separation2
- Backflow1
- Component Missing1
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Leak/Splash; Separation Failure
MalfunctionMar 20, 2026Backflow
CUSTOMER REPORTED THE ONE WAY VALVES ARE NOT WORKING LIKE THEY ARE SUPPOSED TO, BLOOD BACKS UP INTO THE LINE.
Patient problems: Insufficient Information
MAUDE report 24650241 ↗MalfunctionAug 7, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: "IT WAS REPORTED BY THE CUSTOMER THAT THE IV TUBING HAD SEVERAL ISSUES, INCLUDING MISSING CONNECTOR ENDS, LEAKING AT THE HUB, AND BREAKING BETWEEN THE STOPCOCKS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22744034 ↗MalfunctionAug 1, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT THE SUPPLY CAME APART AT 3 PLACES DURING AN EGD COLONOSCOPY PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22692780 ↗MalfunctionJul 21, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE TUBING FELL APART AFTER TIGHTENING ALL CONNECTIONS, TUBING SNAPPED APART, TUBING WOULD NOT PRIME, ROLLER CLAMP WAS MISSING THE ROLLER COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22561220 ↗MalfunctionJul 21, 2025Misassembled; Misassembled
IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION 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 TUBING FELL APART AFTER TIGHTENING ALL CONNECTIONS, TUBING SNAPPED APART, TUBING WOULD NOT PRIME, ROLLER CLAMP WAS MISSING THE ROLLER COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22561213 ↗MalfunctionJul 21, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE TUBING FELL APART AFTER TIGHTENING ALL CONNECTIONS, TUBING SNAPPED APART, TUBING WOULD NOT PRIME, ROLLER CLAMP WAS MISSING THE ROLLER COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22561212 ↗MalfunctionJul 21, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE TUBING FELL APART AFTER TIGHTENING ALL CONNECTIONS, TUBING SNAPPED APART, TUBING WOULD NOT PRIME, ROLLER CLAMP WAS MISSING THE ROLLER COMPONENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22561210 ↗MalfunctionJul 14, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT ABOUT THE TWO EVENTS BELOW 1. PATIENT'S IV HAD COME APART AND FOUND A POOL OF BLOOD IN THE PATIENT'S BED. 2. IV HAD COME APART WITH ONE OPEN END IN THE FLOOR AND THE OTHER END DRIPPING A LARGE POOL OF BLOOD ON THE FLOOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22494231 ↗MalfunctionJul 14, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT ABOUT THE TWO EVENTS BELOW. 1. PATIENT'S IV HAD COME APART AND FOUND A POOL OF BLOOD IN THE PATIENT'S BED. 2. IV HAD COME APART WITH ONE OPEN END IN THE FLOOR AND THE OTHER END DRIPPING A LARGE POOL OF BLOOD ON THE FLOOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22494185 ↗MalfunctionJul 14, 2025Component Missing; Component Missing
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS MISSING A END CAP. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE BLUE CAPS ON THE PORTS WERE MISSING WHEN PACKAGED OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22494169 ↗MalfunctionJul 10, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT TUBING HAD A CRACK, LEAKED AND THEN BROKE ON INDUCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22465765 ↗MalfunctionJul 8, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS KINKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY COULD NOT GET THE FLUIDS OR MEDICATIONS TO FLOW. UNTUCKED THE ARMS AND FOUND THE IV TUBING KINKED. THIS WAS A CAROTID CASE THAT HAD NITROGLYCERIN AND LEVOPHED THAT WAS BEING ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22452130 ↗MalfunctionJul 8, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE IV TUBING LEAKING DURING THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22451508 ↗MalfunctionJul 8, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE TUBING BROKE BETWEEN THE STOPCOCK JOINT AND BLOOD BACK FLOWED ALL THE WAY TO THE BROKEN JOINT BEFORE IT WAS NOTICED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22451129 ↗MalfunctionJul 8, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE IV TUBING CAME DISCONNECTED TWICE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22449464 ↗MalfunctionJul 8, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT IV TUBING BROKE BETWEEN THE 2 STOPCOCKS. IT WAS NOT NOTICED UNTIL BLOOD HAD BACK FLOWED ALL THE WAY TO THE BROKEN AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22432751 ↗MalfunctionJul 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2025 - FOUND IV TUBING LEAKING DURING THE SURGERY. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: IS THE LOT NUMBER KNOWN? NO WERE THERE ANY ADVERSE EVENTS ASSOCIATED WITH THIS INCIDENT? POTENTIAL PATIENT SAFETY AND INCREASED RISK OF INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22401349 ↗MalfunctionJul 3, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK HAD DISCONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2025 - IV TUBING CAME DISCONNECTED TWICE DURING SURGERY. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: IS THE LOT NUMBER KNOWN? NO. WERE THERE ANY ADVERSE EVENTS ASSOCIATED WITH THIS INCIDENT? PATIENT SAFETY AND INCREASED RISK OF INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22401347 ↗MalfunctionJul 3, 2025Defective Component; Defective Component
IT WAS REPORTED THAT THE BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK HAD KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 6/10/25 - COULD NOT GET THE FLUIDS OR MEDICATIONS TO FLOW. UNTUCKED THE ARMS AND FOUND THE IV TUBING KINKED. THIS WAS A CAROTID CASE THAT HAD NITROGLYCERIN AND LEVOPHED THAT WAS BEING ADMINISTERED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: IS THE LOT NUMBER KNOWN? NO WERE THERE ANY ADVERSE EVENTS ASSOCIATED WITH THIS INCIDENT? DELAY OF TREATMENT IN A CRITICAL CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22401262 ↗MalfunctionJun 26, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK HAD DISCONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 6/3/25 - IV TUBING DISCONNECTIONS. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: IMPACTED LOT NUMBER: UNKNOWN. WERE THERE ANY ADVERSE EVENTS ASSOCIATED WITH THIS INCIDENT? POTENTIAL PATIENT SAFETY AND INFECTION RISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22342265 ↗MalfunctionJun 26, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK HAD DISCONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 6/3/25 - IV DISCONNECTING ISSUES. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: IMPACTED LOT NUMBER: UNKNOWN. WERE THERE ANY ADVERSE EVENTS ASSOCIATED WITH THIS INCIDENT? POTENTIAL PATIENT SAFETY AND INFECTION RISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22342264 ↗MalfunctionJun 26, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK HAD DISCONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2025 - IV DISCONNECTING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: IMPACTED LOT NUMBER: UNKNOWN. WERE THERE ANY ADVERSE EVENTS ASSOCIATED WITH THIS INCIDENT? POTENTIAL PATIENT SAFETY AND INFECTION RISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341869 ↗MalfunctionJun 26, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK HAD DISCONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 6/3/25 - IV DISCONNECTING ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: IMPACTED LOT NUMBER: UNKNOWN. WERE THERE ANY ADVERSE EVENTS ASSOCIATED WITH THIS INCIDENT? POTENTIAL PATIENT SAFETY AND INFECTION RISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341854 ↗MalfunctionJun 26, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK HAD DISCONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV TUBING DISCONNECTING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: IMPACTED LOT NUMBER: UNKNOWN. WERE THERE ANY ADVERSE EVENTS ASSOCIATED WITH THIS INCIDENT? POTENTIAL PATIENT SAFETY AND INFECTION RISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341852 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.