MaxPlus MPX5301-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885403237225), received between Feb 24, 2020 and Sep 10, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITEM IS LEAKING, LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022169 ↗
• MalfunctionSep 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITEM IS LEAKING, LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23021993 ↗
• MalfunctionAug 8, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22759009 ↗
• MalfunctionOct 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: WE'VE RECEIVED THE FOLLOWING COMPLAINT FORM OUR CLINICAL STAFF WHEN USING YOUR MPX5301-C, PLEASE ADVISE: WE HAVE RECENTLY FOUND SEVERAL IV ADAPTERS IN SDS THAT ARE LEAKING WITH SUSPECTED HOLE/TEAR IN THE LINE. CUSTOMER RESPONSE: 1. KINDLY PROVIDE THE DATE OF EVENT. THERE WERE 3 DIFFERENT OCCURRENCES OVER THE LAST WEEK, THE MOST RECENT BEING FRIDAY (B)(6) 2024. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. THERE WAS NO HARM CAUSED TO THE PATIENTS THAT WE ARE AWARE OF. ALL 3 ADAPTERS WERE FOUND TO BE LEAKING ONCE THEY WERE ATTACHED TO A PATIENT AND IV FLUIDS WERE INFUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352270 ↗
• MalfunctionOct 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS. CONNECTOR AND Y-SITE WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: WE'VE RECEIVED THE FOLLOWING COMPLAINT FORM OUR CLINICAL STAFF WHEN USING YOUR MPX5301-C, PLEASE ADVISE: WE HAVE RECENTLY FOUND SEVERAL IV ADAPTERS IN SDS THAT ARE LEAKING WITH SUSPECTED HOLE/TEAR IN THE LINE. CUSTOMER RESPONSE: 1. KINDLY PROVIDE THE DATE OF EVENT. THERE WERE 3 DIFFERENT OCCURRENCES OVER THE LAST WEEK, THE MOST RECENT BEING FRIDAY (B)(6) 2024. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. THERE WAS NO HARM CAUSED TO THE PATIENTS THAT WE ARE AWARE OF. ALL 3 ADAPTERS WERE FOUND TO BE LEAKING ONCE THEY WERE ATTACHED TO A PATIENT AND IV FLUIDS WERE INFUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352129 ↗
• MalfunctionOct 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: WE'VE RECEIVED THE FOLLOWING COMPLAINT FORM OUR CLINICAL STAFF WHEN USING YOUR MPX5301-C, PLEASE ADVISE: WE HAVE RECENTLY FOUND SEVERAL IV ADAPTERS IN SDS THAT ARE LEAKING WITH SUSPECTED HOLE/TEAR IN THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352124 ↗
• MalfunctionOct 25, 2021Material Separation; Separation Failure; Material Separation; Separation Failure

  IT WAS REPORTED THAT MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE HAD THE COMPONENTS SEPARATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE HAVING ISSUES WITH THIS EXTENSION SET PULLING APART WHILE CONNECTED TO THE IV PUMP LINE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12694078 ↗
• MalfunctionFeb 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED FROM THE INFUSION CENTER THAT THE EXTENSION TUBING SET NAC-Y NEEDLE-FREE VALVE LEAKED DURING A BLOOD TRANSFUSION. WHEN THE THE CUROS ALCOHOL CAP WAS REMOVED FROM THE NEEDLE-FREE VALVE, THE ENTIRE ALCOHOL PAD INSIDE OF THE CUROS ALCOHOL CAP WAS SATURATED WITH BLOOD. IT WAS NOTED THAT THE PATIENT HAD A CHEST PORT THAT HAD NOT BEEN UTILIZED AND THE LEAK WAS NOT IMMEDIATELY IDENTIFIED UNDER THE PATIENT' SHIRT. THE TUBING SET WAS REPLACED. THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9746068 ↗
• MalfunctionFeb 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED FROM THE INFUSION CENTER THAT THE EXTENSION TUBING SET LEAKED UNDER THE OPSITE AT THE CONNECTION TO THE PATIENT'S IV SITE DURING A BLOOD TRANSFUSION. THE OPSITE HAD TO BE REPLACED. THE LEAK CONTINUED DESPITE ATTEMPTS AT TIGHTENING THE CONNECTION. THE EXTENSION SET WAS REMOVED AND A STRAIGHT CONNECTION WAS MADE BETWEEN THE BLOOD ADMINISTRATION TUBING AND THE PATIENT'S IV SITE. THE CUSTOMER DOES NOT THINK THAT LEAVING THE EXTENSION SET OFF DURING A BLOOD TRANSFUSION IS SAFE, SO THEY DECIDED TO ADD A NEEDLELESS CONNECTOR TO THE PATIENT'S IV SITE IN THE EVENT IF ANOTHER LEAK SHOULD OCCUR. THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745996 ↗