MaxGuard MFS102Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885403236334), received between Jun 16, 2022 and May 26, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED, THAT THE BD MAXGUARD¿ FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S). WITH THE DIAL OPEN, UNABLE TO PRIME. ALSO AFTER PRIMING, UNABLE TO INFUSE AT THE PRESCRIBED RATE OR OPEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ARE YOU CONTINUING TO HAVE ISSUES WITH MFS102? YES. HAS ANYONE ELSE REPORTED ISSUES? THE PROBLEM APPEARS TO BE WIDESPREAD (I.E. NOT SPECIFIC TO A PARTICULAR LOT, ETC.).THE ERRORS INCLUDE PRIMING WITH THE DIAL OPEN, UNABLE TO PRIME. ALSO AFTER PRIMING, UNABLE TO INFUSE AT THE PRESCRIBED RATE OR OPEN. THUS, FAR WE HAVE SEEN AT LEAST A DOZEN INCIDENCES OF VARIOUS REPORTED ISSUES. CONSEQUENTLY, THIS HAS RESULTED IN WASTING MEDICATIONS AND DECREASE IN PATIENT SATISFACTION. I COULD BE AVAILABLE TOMORROW AT 10AM OR ANYTIME AFTER 2PM. IF THESE TIMES DON¿T WORK, WE COULD LOOK INTO NEXT WEEK AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17014741 ↗
• MalfunctionMar 31, 2023Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT THE BD MAXGUARD FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S)EXPERIENCED FLOW ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR THE FAILED PRIME FOR THIS TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657610 ↗
• MalfunctionMar 29, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE BD MAXGUARD¿ FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) FAILED TO PRIME DUE TO BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE ANOTHER INCIDENT WITH TUBING ISSUE REPORT ON FRIDAY 3/10/23. FAILED PRIME FOR THIS TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640425 ↗
• MalfunctionMar 28, 2023Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT 2 OF THE BD MAXGUARD FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S)EXPERIENCED FLOW ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLEASE SEE VIDEO FOR THE FAILED PRIME FOR THIS TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16633052 ↗
• MalfunctionMar 27, 2023Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT 10 BD MAXGUARD FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED FLOW ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I¿D LIKE TO REPORT THE BELOW ADMINISTRATION SET FOR GRAVITY INFUSION HAS BEEN HAVING PROBLEM WITH INFUSION. WE COULD NOT PRIME THE TUBING; THE RESULTS ARE EITHER WASTING THE DRUGS AND/OR SWITCHING OUT THE TUBING SET. THIS HAS RESULTED IN DELAY OF CARE AND/OR AT RISK FOR POTENTIAL LINE INFECTION ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620193 ↗
• MalfunctionMar 8, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT USAGE WITH THE BD MAXGUARD FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) LED TO BEING OCCLUDED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE ISSUE HAPPENED AGAIN OF HAVING FLOW ISSUES WITH THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16500548 ↗
• MalfunctionMar 1, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXGUARD¿ FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) WAS OCCLUDED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " SITUATION: FLUID BAG IS SPIKED; THE FLOW CONTROLLER IS SET TO OPEN AND THE LINE PRIMES WITHOUT ISSUE. WHEN THE CONTROLLER IS SET TO THE RATE DECIDE THERE IS NO FLOW. OCCURRED 7 TIMES IN LAST TOW DAYS. RNS MOVED TO ANOTHER DEVICE OR USED ALARIS PUMP. BACKGROUND: THE DEVICE IS DESIGNED TO BE USED IN OPEN MODE TO PRIME THE TUBING AND THEN THE RN CAN SET THE RATE OF FLOW PER ORDERED RATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464669 ↗
• MalfunctionFeb 23, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT DURING USE WITH BD MAXGUARD FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) DEVICE WAS OCCLUDED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITUATION: FLUID BAG IS SPIKED; THE FLOW CONTROLLER IS SET TO OPEN AND THE LINE PRIMES WITHOUT ISSUE. WHEN THE CONTROLLER IS SET TO THE RATE DECIDE THERE IS NO FLOW. OCCURRED 7 TIMES IN LAST TOW DAYS. RNS MOVED TO ANOTHER DEVICE OR USED ALARIS PUMP. BACKGROUND: THE DEVICE IS DESIGNED TO BE USED IN OPEN MODE TO PRIME THE TUBING AND THEN THE RN CAN SET THE RATE OF FLOW PER ORDERED RATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432427 ↗
• MalfunctionJun 17, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD GRAVITY ADMINISTRATION SET EXPERIENCED BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE FLOW CONTROLLER WAS OPEN BUT THE IV FLUIDS WOULD NOT FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734595 ↗
• MalfunctionJun 16, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXGUARD FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT LETS YOU RUN THE IV SOLUTION THROUGH IT TO PRIME IT BUT ONCE HOOKED TO A PATIENT IV THE TUBING WILL NOT FLOW. TRIED MULTIPLE TUBINGS FROM SAME LOT AND HAVING SAME ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14722417 ↗
• MalfunctionJun 16, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE SEVEN BD MAXGUARD FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED MALFUNCTION DIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 7 OF OUR HOME INFUSION PATIENTS REPORTED THAT WHEN THEY USED THE DIAL TO SET THEIR FLOW RATE, THE MEDICATION WOULD NOT FLOW THROUGH AT ALL (SO THEY WOULD NOT GET THEIR DOSES); BUT WHEN THE DIAL IS TURNED UP TO MAX FLOW RATE THE MEDICATION CAN FLOW THROUGH FOR PRIMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14713991 ↗