MaxGuard MFS141Recalls & reported problems
BD Switzerland Sàrl · Flow Controller Extension Set, with Needless Y-Site, 36 cm (14 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 flow controller extension set has 40 adverse event reports, all describing malfunctions such as blocked or occluded flow, leaks and missing parts; no deaths or injuries were reported. One open recall began in August 2022 because product labels showed the wrong expiration year, which could compromise product integrity and raise leak or 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
- 40
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10885403236471), received between Apr 25, 2022 and Sep 16, 2024 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (23 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-1755-2022 · Root cause: Error in labeling · FDA record ↗
Most reported problems
Device problems
- Complete Blockage23
- Improper Flow or Infusion7
- Leak/Splash5
- Contamination of Device Ingredient or Reagent2
- Defective Component2
- Defective Device2
- Obstruction of Flow2
- Blocked Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2024Blocked Connection; Blocked Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20233449 ↗MalfunctionNov 20, 2023Defective Component; Defective Component
IT WAS REPORTED THAT BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) WAS MISSING A COMPONENT. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: PER CUSTOMER: " A NURSE BROUGHT TO OUR ATTENTION THAT SOME OF OUR "FLOW CONTROLLER EXTENSION" HAVE RECENTLY COME WITHOUT THE PIECE THAT ATTACHES/SCREWS ONTO THE IV CLAVE."
Patient problems: Insufficient Information
MAUDE report 18168901 ↗MalfunctionMar 6, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT DURING USE WITH BD MAXGUARD¿ FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE THE MEDICATION WAS ABLE TO BE PRIMED, HOWEVER, AFTER FLOW DIAL WAS SET THE MEDICATION WAS OCCLUDED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAXGUARD FLOW CONTROLLER SET X 2 DEFECTIVE. ABLE TO PRIME MEDICATION, BUT AFTER FLOW DIAL SET, MEDICATION WOULD NO LONGER FLOW THROUGH THE EXTENSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16492820 ↗MalfunctionMar 4, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FAILURE: FLOW ISSUE ¿ OCCLUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16483444 ↗MalfunctionMar 1, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT DURING USE WITH BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) THE DEVICE WAS CLOGGED. THIS IS THE 3RD OF 3 OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE PRODUCT (X3) WITH THE SAME LOT NUMBER. TRIED TO FLUSH THE TUBING BUT DIDN'T WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16464131 ↗MalfunctionMar 1, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT DURING USE WITH BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) THE DEVICE WAS CLOGGED. THIS IS THE 1ST OF 3 OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE PRODUCT (X3) WITH THE SAME LOT NUMBER. TRIED TO FLUSH THE TUBING BUT DIDN'T WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16464102 ↗MalfunctionMar 1, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT DURING USE WITH BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) THE DEVICE WAS CLOGGED. THIS IS THE 2ND OF 3 OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE PRODUCT (X3) WITH THE SAME LOT NUMBER. TRIED TO FLUSH THE TUBING BUT DIDN'T WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16464101 ↗MalfunctionFeb 20, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED WHILE USING BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) THERE WAS A BLOCKAGE. THIS OCCURRED TWICE THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THAT IS NOT ALLOWING THE FLUID TO RUN THROUGH THE TUBING SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16401892 ↗MalfunctionDec 20, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE BD MAXGUARD FLOW CONTROLLER EXTENSION WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE A PRODUCT THAT HAS BEEN REPORTED AS NOT WORKING AS SHOULD. IT IS THE BD MAXGUARD FLOW CONTROLLER EXTENSION SET. THE REFERENCE NUMBER IS (B)(4) AND LOT NUMBER IS 22039149. WE HAVE EXPERIENCE ISSUES WITH THE DIAL NOT FLOWING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16018612 ↗MalfunctionDec 12, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD MAXGUARD FLOW CONTROLLER EXTENSION PREVENTED ANY FLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SEVERAL HAVE BEEN DISCOVERED TO BE DEFECTIVE... DEVICE PLACED IN THE IV LINE OF THIS PATIENT PREVENTED ANY FLOW. PATIENT DID NOT RECEIVE THE PROPER DOSE OF ANESTHETIC MEDICATION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15964407 ↗MalfunctionOct 24, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE BD MAXGUARD FLOW CONTROLLER EXTENSION SET EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITEM IS NOT DRIPPING AS IT SHOULD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15663925 ↗MalfunctionAug 23, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE IV FLUIDS WOULD NOT FLOW THROUGH THE DIAL A FLOW ¿ EVEN WHEN OPENED FULLY TO 250ML/HR. IV FLUIDS INFUSED WELL WHEN DIAL A FLOW REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15279539 ↗MalfunctionAug 23, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE IV FLUIDS WOULD NOT FLOW THROUGH THE DIAL A FLOW ¿ EVEN WHEN OPENED FULLY TO 250ML/HR. IV FLUIDS INFUSED WELL WHEN DIAL A FLOW REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15279413 ↗MalfunctionAug 3, 2022Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT 4 BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED DIFFICULT TO CLAMP OR UNCLAMP TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV FLUIDS NOT INFUSING THOUGH PATIENT IV WAS PATENT, BRISK BLOOD RETURN AND FLUSHING WELL. THIS ISSUE HAS HAPPENED WITH 3 OTHER PATIENTS. NO HARM TO PATIENTS HAPPENED. A CRNA REPORTED THAT THE FLOW CONTROLLER HAD TO REMOVED FROM THE IV TUBING IN THE OR FOR ANOTHER PATIENT AS IT WASN'T WORKING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15158846 ↗MalfunctionAug 3, 2022Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT THE BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED DIFFICULT TO CLAMP OR UNCLAMP TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV FLUIDS NOT INFUSING THOUGH PATIENT IV WAS PATENT, BRISK BLOOD RETURN AND FLUSHING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15158845 ↗MalfunctionAug 3, 2022Complete Blockage; Leak/Splash; Contamination of Device Ingredient or Reagent; Complete Blockage; Leak/Splash; Contamination of Device Ingredient or Reagent
IT WAS REPORTED THAT THE BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED OCCLUSION, LEAKAGE AND FOREIGN MATTER IN FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GOT AN EMAIL FROM THE DOCTOR WHO SAID THAT THE DEVICES WOULD NOT ALLOW FLUID TO FLOW THROUGH DESPITE BEING OPEN. WATER CAME OUT OF THE DEVICE. UNSURE WHETHER THE DEVICE WAS BEING USED FOR EDUCATIONAL PURPOSES. NOT SURE WHETHER THE WATER THAT CAME OUT WAS FOREIGN MATTER OR IF IT WAS PART OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15158709 ↗MalfunctionAug 3, 2022Complete Blockage; Leak/Splash; Contamination of Device Ingredient or Reagent; Complete Blockage; Leak/Splash; Contamination of Device Ingredient or Reagent
IT WAS REPORTED THAT THE BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED OCCLUSION, LEAKAGE AND FOREIGN MATTER IN FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GOT AN EMAIL FROM THE DOCTOR WHO SAID THAT THE DEVICES WOULD NOT ALLOW FLUID TO FLOW THROUGH DESPITE BEING OPEN. WATER CAME OUT OF THE DEVICE. UNSURE WHETHER THE DEVICE WAS BEING USED FOR EDUCATIONAL PURPOSES. NOT SURE WHETHER THE WATER THAT CAME OUT WAS FOREIGN MATTER OR IF IT WAS PART OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15158706 ↗MalfunctionJul 14, 2022Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT THE BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED FLOW ACCURACY ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONTINUE TO EXPERIENCE FLOW FAILURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15020796 ↗MalfunctionJul 8, 2022Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT THE BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) DIAL-A-FLOW IS NOT ALLOWING FLUID TO FLOW PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE RECEIVED SEVERAL CASES OF ITEM NUMBER: MFS141, LOT NUMBER: 22039046 WHERE THE DIAL-A-FLOW IS NOT ALLOWING FLUID TO FLOW PROPERLY. EVEN WHEN THE DEVICE IS SET TO ¿OPEN¿ IT IS VERY DIFFICULT TO FLUSH AND IT SHOULD EASILY FLOW THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14961756 ↗MalfunctionJul 8, 2022Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT THE BD MAXGUARD¿ FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE HAD FLOW ISSUES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECEIVED SEVERAL CASES OF ITEM NUMBER MFS141, LOT NUMBER 22039046 WHERE THE DIAL-A-FLOW IS NOT ALLOWING FLUID TO FLOW PROPERLY. EVEN WHEN THE DEVICE IS SET TO ¿OPEN¿ IT IS VERY DIFFICULT TO FLUSH AND IT SHOULD EASILY FLOW THROUGH."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14955378 ↗MalfunctionJul 7, 2022Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT SEVERAL BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED ISSUE WITH THE REGULATORS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE BEEN RECEIVING COMPLAINTS FROM MULTIPLE NURSES STATING THAT THE IV SET REGULATORS (DIAL A FLOW) ARE MALFUNCTIONING. THE REGULATORS ARE WORKING PROPERLY WHEN THEY PRIME, FLUSH THE LINE, AND TURN THE DRIP OFF. ONCE THEY RESET THE DIAL TO THE APPROPRIATE DRIP RATE, AFTER TURNING IT OFF, THE INTERMITTENT ISSUE OF THE REGULATOR NOT FLOWING OCCURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14950065 ↗MalfunctionJun 27, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT 2 BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE BEEN TOLD OF 2 OF THE BD MAXGUARD FLOW CONTROLLER EXT SETS (DIAL-A-FLOWS) NOT WORKING AT ALL. THEY ARE ABLE TO PRIME THE CONTROLLER EXTENSION BUT AFTER PRIMING NO FLOW IS ALLOWED NO MATTER THE RANGE THAT IS SELECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14834389 ↗MalfunctionMay 18, 2022Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED THAT THE BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSES ARE HAVING ISSUES WITH THE FLOW REGULATORS (MFS141) NOT WORKING PROPERLY. THEY REPORT A HARD RESISTANCE IN THE BEGINNING AND THEN THE FLOW RATE ALMOST STOPS AT SOME SPOTS OR NOT BE AS IT SHOULD, I.E. AT 100 THERE WAS NO FLOW BUT AT FULL OPEN THEY HAD FLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14429285 ↗MalfunctionMay 18, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 2 BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IF YOU TAKE A SYRINGE AND ATTEMPT TO FLUSH IT, IT WILL NOT GO THROUGH THE DIAL-A-FLOW. THE LIQUID LEAKS FROM WITHIN THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14427723 ↗MalfunctionMay 16, 2022Defective Component; Defective Component
IT WAS REPORTED THAT 12 BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) WERE UNABLE TO HAVE THEIR TUBING CLAMPED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE NOT ABLE TO WORK THROUGH THE DIAL A FLOWS. WE HAD TO RESTART AN IV RECENTLY DUE TO A DEFECTIVE DIAL A FLOW. THE FLUIDS STOPPED RUNNING AND THE IV CLOTTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14407067 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.