MaxGuard MX9128Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10885403237621), received between Jul 18, 2018 and Mar 5, 2026 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Backflow” (7 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Leak/Splash; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515368 ↗
• MalfunctionOct 12, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: I RECEIVED REPORTS OF ITEM #MX9128 ¿MAXGUARD 15 DROP ADMINISTRATION SET WITH 3 NEEDLESS Y-SITES BEING VERY DIFFICULT TO CONNECT TO IV CANNULA HUBS. MULTIPLE END USERS ARE HAVING THIS SAME ISSUE, ALL WITH LOT #24069036. THE END OF THE TUBING BROKE DURING ONE INCIDENT, HOWEVER, THAT ITEM WAS NOT KEPT. THE OVERALL CONSENSUS IS THE ITEM BEING ¿TOUGH TO HOOK UP¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434969 ↗
• MalfunctionMay 14, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) WAS MISSING COMPONENT THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE CONNECTING PIECE MISSING TO CONNECT TO THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311080 ↗
• MalfunctionDec 11, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: DO YOU KNOW WHO I SHOULD REACH OUT TO REGARDING THE BD MAXGUARD IV TUBING? AT PESC AND PSC WE ARE SEEING A LOT OF LEAKING AT THE CONNECTION SITE OF THE TUBING AND THE IV. THE TUBING DOES NOT CONNECT WELL TO THE IV. YOU MUST, AS BEST AS YOU CAN, TRY TO OVERTIGHTEN THE TUBING FOR IT NOT TO COME LOOSE. IT CAN BE DIFFICULT TO DO BECAUSE YOU HAVE TO GRIP THE IV TIGHTLY AND THERE IS NOT A LOT OF ROOM TO HOLD ONTO IT. REF# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18308029 ↗
• MalfunctionAug 9, 2023Material Separation; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17493791 ↗
• MalfunctionAug 9, 2023Material Separation; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17493789 ↗
• MalfunctionJul 26, 2023Material Discolored; Material Discolored

  IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF BD MAXGUARD¿ ADMINISTRATION SETS WITH NEEDLELESS Y-SITE HAD DISCOLORED DRIP CHAMBERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LAST NIGHT I NOTICED THAT SEVERAL OF THE DRIP CHAMBERS ON THE PRIMARY TUBING SETS WERE DISCOLORED. THEY ALL SEEM TO HAVE COME FROM THE SAME 2 LOTS. I AM NOT SURE IF THE MANUFACTURER SENT ANY NOTICES REGARDING THIS CHANGE IN PRODUCT OR IF THERE IS SOMETHING WRONG WITH THE INTEGRITY OF THE PRIMARY TUBING FROM THESE LOTS. IN THE MEANTIME, I PULLED THEM FROM THE NURSE SERVERS AND THEY ARE CURRENTLY AT THE NURSES STATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17400401 ↗
• MalfunctionApr 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD MAXGUARD¿ ADMINISTRATION SET WITH NEEDLELESS Y-SITE PORT SEPARATED FROM THE TUBING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PORT CAME OFF THE TUBING DURING USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714171 ↗
• MalfunctionMar 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED WHILE USING BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) THE CONNECTION WAS SEPARATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THEY ARE EXPERIENCING ISSUES WITH EXTENSION SETS SEPARATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497658 ↗
• MalfunctionMar 6, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE COMPONENTS SEPARATED AND BLOOD LEAKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD AN ISSUE (COMPONENT SEPARATION) THE LEAD TO BLOOD EXPOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16493034 ↗
• MalfunctionDec 5, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXGUARD¿ ADMINISTRATION SET WITH NEEDLELESS Y-SITE LEAKED BLOOD ONTO THE PATIENT'S BEDDING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY ARE STATING THAT THERE WERE CHANGES MADE TO THE PRODUCT'S HUB THAT AFFECT THE PATIENTS WHEN THE PRODUCT USED TO CONNECT SEAMLESSLY. THE PART WHERE THE TUBING IS HOOKED TO THE IV SITE IS DIFFICULT TO CONNECT TO THE IV SITE. IT IS LEAKING AND GETTING BLOOD ON THE BEDDING. TRYING TO ATTACH IT TO THE PATIENT CAUSES THEM TO APPLY PRESSURE TO THE PATIENT WHICH CAUSES THE PATIENT PAIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921230 ↗
• MalfunctionSep 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT 1 BD MAXGUARD¿ ADMINISTRATION SET WITH NEEDLELESS Y-SITE EACH FROM LOTS 22059113 AND 22059057 WERE BLOCKED AND WOULDN'T ALLOW FLUID PAST THE FIRST HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM RECEIVING NUMEROUS COMPLAINTS ABOUT THIS IV TUBING FROM END USERS MAINLY IN OUR PRE-OP DEPARTMENT. THIS TIME IT IS A DIFFERENT LOT #. STAFF IS REPORTING THAT THE TUBING WILL NOT ALLOW FLUIDS TO MOVE PASS THE FIRST HUB. NO KINKS WERE FOUND. REQUIRING THEM TO OPEN A NEW SET AND EXCHANGE OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15433493 ↗
• MalfunctionSep 15, 2022No Flow; No Flow

  IT WAS REPORTED WHILE USING BD 112 IN 15 DROP IV ADMINISTRATION SET THE TUBING WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM RECEIVING MORE COMPLAINTS ABOUT THIS IV TUBING FROM END USERS MAINLY IN OUR PRE-OP DEPARTMENT. STAFF REPORTED THAT TUBING DIDN'T WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432358 ↗
• MalfunctionSep 15, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED WHILE USING BD 112 IN 15 DROP IV ADMINISTRATION SET THE TUBING WAS KINKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF REPORT HAVING TUBING RECENTLY THAT WAS KINKED REALLY BAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432284 ↗
• MalfunctionAug 5, 2022Misassembled; Misassembled

  IT WAS REPORTED THAT THE BD PRIMARY GRAVITY IV ADMINISTRATION SETS EXPERIENCED TUBING DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD AN MX9128 IV SET - LOT NUMBER 22059056 THAT WHEN WE TRIED TO USE IT THE ROLLER CLAMP WAS UPSIDE DOWN ON THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15174885 ↗
• MalfunctionMay 19, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) WAS BUILT UPSIDE DOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS SET WAS BUILT UPSIDE DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14437877 ↗
• MalfunctionMay 13, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 3 112 IN 15 DROP IV ADMINISTRATION SETS LEAKED WHILE USING THE SYRINGE TO INJECT IV MEDICINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE USING BD MAXGUARD 15 DROPS/ML IV SET PORTS LEAKING WHEN USING 3 MLL SYRINGE TO INJECT IV MEDICINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822837 ↗
• MalfunctionMar 16, 2021Backflow; Backflow

  IT WAS REPORTED THAT A 112 IN 15 DROP IV ADMINISTRATION SET HAD FLOW ISSUES DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT WHEN INJECTING PROPOFOL INTO THE SMARTSITE PORT THE DRUG WENT UP INTO THE IV BAG VS TO THE PATIENT. VERBATIM: DR. XXXXXX HAD AN INCIDENT TODAY IN WHICH HE WAS INJECTING PROPOFOL IN THE SMARSITE PORT AND THE DRUG WENT UP INTO THE IV BAG VS TO THE PATIENT. HE HAS A VIDEO ON HIS PHONE BUT WOULD NOT GO THROUGH FOR US TO SEE. NO ADVERSE EVENT WAS NOTED. A NEW TUBING WAS HUNG WHICH WORKED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11492039 ↗
• MalfunctionJan 27, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 112 IN 15 DROP IV ADMINISTRATION SETS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: MX9128 BATCH/ LOT #: UNKNOWN. THEY HAVE HAD ISSUES THE LAST COUPLE OF DAYS WITH LEAKING FROM CAP CLOSEST TO THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11236932 ↗
• MalfunctionDec 29, 2020Backflow; Backflow

  IT WAS REPORTED THAT BLOOD BACKFLOWED INTO THE 112 IN 15 DROP IV ADMINISTRATION SET TUBING DURING THE INFUSION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT BLOOD IS BACKING UP INTO THE TUBING."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11087244 ↗
• MalfunctionDec 29, 2020Backflow; Backflow

  IT WAS REPORTED THAT BLOOD BACKFLOWED INTO THE 112 IN 15 DROP IV ADMINISTRATION SET TUBING DURING THE INFUSION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT BLOOD IS BACKING UP INTO THE TUBING."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11087243 ↗
• MalfunctionDec 29, 2020Backflow; Backflow

  IT WAS REPORTED THAT BLOOD BACKFLOWED INTO THE 112 IN 15 DROP IV ADMINISTRATION SET TUBING DURING THE INFUSION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT BLOOD IS BACKING UP INTO THE TUBING.".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11087151 ↗
• MalfunctionDec 22, 2020Backflow; Backflow

  IT WAS REPORTED THAT 112 IN 15 DROP IV ADMINISTRATION SET HAD BLOOD BACKFLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MX9128, BATCH NO: 20065593. IT WAS REPORTED THAT BLOOD IS BACKING UP INTO THE TUBING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11061067 ↗
• MalfunctionSep 23, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 112 IN 15 DROP IV ADMINISTRATION SET CAME APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MX9128 BATCH NO: 19127048. IT WAS REPORTED THAT BD MAXGUARD 15 DROP ADMINISTRATION SET WITH 3 NEEDLELESS Y-SITES CAME APART VERY EASY WHILE HOOKED UP TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10575232 ↗
• MalfunctionDec 4, 2019Backflow; Backflow

  IT WAS REPORTED THAT WHEN INJECTING INTO THE LINE THE MEDICATION BACK-FLOWED INTO THE BAG, THE ISSUE OF "BACK FLOW" HAPPENED DAILY.

  Patient problems: No Information

  MAUDE report 9413577 ↗