MaxGuard MX4436Recalls & reported problems
BD Switzerland Sàrl · 15 Drop Administration Set, with 3 needleless Y-sites, removable 3-port manifold and removable 4-way stopcock 421 cm (166 in) · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD MaxGuard administration set delivers fluids through an intravenous line. Its 30 reports mostly describe tubing that leaks, blocks, disconnects, bends, or allows blood to flow backward; there were no deaths or injuries. One open recall began in August 2022 because some product labels listed the wrong expiration year, which could allow leaks and increase infection risk if expired product is used.
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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10885403237478), received between Nov 2, 2020 and Mar 19, 2025 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (8 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Aug 1, 2022Open, Classified
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
Z-1756-2022 · Root cause: Error in labeling · FDA record ↗
Most reported problems
Device problems
- Leak/Splash8
- Complete Blockage7
- Defective Component4
- Backflow3
- Disconnection3
- Break2
- Material Separation2
- Misassembled During Installation2
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD WAS KINKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM VERBATIM: I WERE LOOKING AT THE SAMPLES WE NOTICED THAT THERE WAS QUITE A BEND IN THE TUBING ON THE ONE END. WE OPENED THE PACKAGE TO SEE IF WE COULD WORK THE BEND/KINK OUT OF IT BUT THE MEMORY OF THE PLASTIC RETAINED THE BEND IN THE TUBING. WHEN THERE IS FLUID RUNNING THROUGH THE TUBING ARE THERE ANY CONCERNS WITH THIS BEND?
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21649375 ↗MalfunctionJul 17, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19762211 ↗MalfunctionJun 4, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19457795 ↗MalfunctionJun 4, 2024Complete Blockage; Defective Component; Complete Blockage; Defective Component
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD WAS DEFORMED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE LOCATED 3 ANESTHESIA TUBING SETS THAT HAVE PORTS (MEDICATION ADMINISTRATION PORT) BACKWARDS. THIS PORT IS THE PORT CLOSEST TO THE PATIENT AND IT FORCES THE MEDICATIONS TO BE ADMINISTERED TOWARDS THE IV BAG INSTEAD OF THE PATIENT. THE STOPCOCKS ARE FREQUENTLY COMING LOOSE AND WE ARE HAVING FLUIDS AND MEDICATIONS LEAKING ONTO THE FLOOR AS WELL. PRODUCT NUMBER - (B)(4). LOT NUMBER - 24019107
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19457701 ↗MalfunctionJun 3, 2024Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
IT WAS REPORTED THAT BD 166-IN 15 DROP ADMIN/REMOVABLE IV TUBING BECAME DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE IV TUBING BECAME DISCONNECTED AT THE STOPCOCK. THE OPENING ALLOWED BLOOD FLOW TO COME BACK UP THE TUBING AND ONTO THE FLOOR. THIS PATIENT WAS ALSO ANTICOAGULATED FROM THEIR PROCEDURE SO LUCKILY IT WAS CAUGHT RELATIVELY QUICKLY AS IT COULD'VE CAUSED SIGNIFICANT BLEEDING. THIS OPENED UP ONTO THE FLOOR AND OPENED A POSSIBLE SOURCE OF INFECTION FOR THE PATIENT. THIS IS A FREQUENT PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19449032 ↗MalfunctionMay 1, 2024Material Separation; Material Separation
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19225842 ↗MalfunctionApr 25, 2024Backflow; Leak/Splash; Backflow; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD HAD BACKFLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM STOPCOCK BECAME LOOSE WHILE PATIENT WAS SQUIRMING IN BED. THEY HAD JUST HAD A CRANIOTOMY FOR A BRAIN TUMOR. THIS CAUSED BLOOD TO BACK UP INTO THE PATIENT'S IV LINE AND OPENED UP TUBING FOR POTENTIAL INFECTION. CATALOG#: MX4436.
Patient problems: Insufficient Information
MAUDE report 19183703 ↗MalfunctionApr 25, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component
IT WAS REPORTED, THAT BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED, BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED, A COMPLAINT VIA EMAIL. ATTEMPTED TO TWIST THE STOPCOCK TO REMOVE IT, AND THE TUBING BROKE OFF WITH MINIMAL FORCE. CATALOG#: MX4436.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19183568 ↗MalfunctionApr 25, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19181091 ↗MalfunctionApr 25, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: WE HAVE HAD MULTIPLE PATIENTS COME THROUGH SURGERY AND THEIR IV TUBING BECOMES DISCONNECTED AT THE STOPCOCK. TODAY, WE RECEIVED A PATIENT IN PACU AFTER SURGERY AND THE CLAVE CLOSEST TO THE PATIENT WAS BACKWARDS. IT WAS FORCING THE MEDICATIONS TO BE FLUSHED TOWARDS THE BAG INSTEAD OF THE PATIENT. CATALOG#: MX4436.
Patient problems: Insufficient Information
MAUDE report 19180988 ↗MalfunctionDec 12, 2023Leak/Splash; Defective Component; Leak/Splash; Defective Component
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: VERBATIM: CUSTOMER IS SAYING TUBING IS DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18315305 ↗MalfunctionSep 21, 2023Component Missing; Component Missing
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD TUBING CLAMP WAS MISSING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: REPORTED ISSUE: THE ROLLER CLAMP ON THE TUBING WAS NOT PRESENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17795499 ↗MalfunctionSep 1, 2023Packaging Problem; Packaging Problem
IT WAS REPORTED WHILE USING BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE, STOPCOCK AND MANIFOLD THE STERILITY WAS COMPROMISED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEALS ON 2 DIFFERENT MAX GUARDS WERE IMPROPERLY FOLDED LEADING TO QUESTIONS ABOUT STERILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17671280 ↗MalfunctionJun 2, 2023Break; Break
IT WAS REPORTED THAT 2 BD MAXGUARD¿ EXTENSION SETS WITH NEEDLELESS Y-SITE, STOPCOCK AND MANIFOLD EACH FROM LOTS 22119025 AND 2319085 HAD ISSUES WITH BREAKAGE NEAR THE MANIFOLD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MX4436 IS BREAKING NEAR THE MANIFOLD THIS OCCURRED 2X W/ 2 DIFFERENT LOT #'S. 3. WAS THIS NOTED ON BEFORE USE OR DURING/AFTER USE? THIS WAS NOTED PRIOR TO USE. 4. WAS THERE ANY PATIENT INVOLVEMENT? WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY? NO. 5. WHAT PROCEDURE WAS BEING DONE DURING THE INCIDENT? TUBING WAS PULLED TO PREPARE PATIENT FOR SURGERY. 6. WAS THERE ANY LEAKAGE FOUND? NO ITEM WAS DEFECTIVE IN PACKAGING. 7. WHAT MEDICATION/SOLUTION WAS USED DURING THE INCIDENT? NONE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17052220 ↗MalfunctionJun 2, 2023Break; Break
IT WAS REPORTED THAT 2 BD MAXGUARD¿ EXTENSION SETS WITH NEEDLELESS Y-SITE, STOPCOCK AND MANIFOLD EACH FROM LOTS 22119025 AND 2319085 HAD ISSUES WITH BREAKAGE NEAR THE MANIFOLD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MX4436 IS BREAKING NEAR THE MANIFOLD THIS OCCURRED 2X W/ 2 DIFFERENT LOT #'S... 3. WAS THIS NOTED ON BEFORE USE OR DURING/AFTER USE? THIS WAS NOTED PRIOR TO USE 4. WAS THERE ANY PATIENT INVOLVEMENT? WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY? NO 5. WHAT PROCEDURE WAS BEING DONE DURING THE INCIDENT? TUBING WAS PULLED TO PREPARE PATIENT FOR SURGERY 6. WAS THERE ANY LEAKAGE FOUND? NO ITEM WAS DEFECTIVE IN PACKAGING 7. WHAT MEDICATION/SOLUTION WAS USED DURING THE INCIDENT? NONE"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17052217 ↗MalfunctionJan 11, 2023Misassembled During Installation; Misassembled During Installation
IT WAS REPORTED WHILE USING BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE THERE WERE FLOW ISSUES. THIS OCCURRED 5 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS IT WAS REPORTED BY CUSTOMER THAT WHILE USING THE BD PRIMARY GRAVITY IV ADMINISTRATION SETS THE PRODUCT WOULD NOT PRIME IS BECAUSE OF THE BLUE BACK CHECK VALVE WAS PUT ON BACKWARDS CAUSING INJECTED MEDICATION TO FLOW UP THE IV BAG RATHER THAN TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16140906 ↗MalfunctionJan 10, 2023No Flow; No Flow
IT WAS REPORTED WHILE USING BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE THERE WERE FLOW ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YESTERDAY WE HAD MULTIPLE SETS THAT THE FLUID WOULD NOT RUN THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16132405 ↗MalfunctionJan 6, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT 6 BD MAXGUARD¿ EXTENSION SETS WITH NEEDLELESS Y-SITE, STOPCOCK AND MANIFOLD WERE BLOCKED AND COULDN'T PRIME DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE 6 MORE OF PRODUCT MAXGUARD MX4436 WITH THE SAMPLE ISSUE FAILURE TO PRIME"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16113457 ↗MalfunctionDec 29, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT 3 OF THE BD MAXGUARD DROP ADMINISTRATION SET WOULD NOT PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITEM WILL NOT PRIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16075048 ↗MalfunctionDec 14, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT 3 BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION OF EVENT(S) WILL NOT PRIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15982987 ↗MalfunctionNov 15, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED WHILE USING BD MAXGUARD DROP ADMINISTRATION SET THERE WERE FLOW ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITEM WILL NOT PRIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15802552 ↗MalfunctionNov 15, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED WHILE USING BD MAXGUARD DROP ADMINISTRATION SET THERE WERE FLOW ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITEM WILL NOT PRIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15802551 ↗MalfunctionOct 31, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT 6 BD MAXGUARD ¿ WERE NOT ABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER EXPLAINED THAT PREOP NURSES HAS EXPERIENCED NOT BEING ABLE TO PRIME IV TUBING ON SIX DIFFERENT OCCASIONS. THEY ALSO TRIED USING A SYRINGE TO FLUSH TUBING AND STILL RECEIVED SAME RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15700838 ↗MalfunctionSep 1, 2022Disconnection; Disconnection
IT WAS REPORTED WHILE USING BD MAXGUARD THE IV SET DISCONNECTED. THIS IS EVENT 2 OF 2. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED 2 DISCONNECTION EVENTS WITH MX4436 THAT OCCURRED LAST WEEK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15342245 ↗MalfunctionSep 1, 2022Disconnection; Disconnection
IT WAS REPORTED WHILE USING BD MAXGUARD THE IV SET DISCONNECTED. THIS IS EVENT 1 OF 2.THERE WAS NO REPORT OF PATIENT IMPACT.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED 2 DISCONNECTION EVENTS WITH MX4436 THAT OCCURRED LAST WEEK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15342026 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.