MaxPlus MP5312-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885403230158), received between Sep 2, 2021 and Aug 6, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (4 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.

• MalfunctionAug 6, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD MAXPLUS¿ PRESSURE RATED EXTENSION SETS WITH NEEDLELESS CONNECTOR WERE DAMAGED/DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAVE A BUNCH OF STOCK IN DC 85 OF THIS ITEM THAT THE CUSTOMER IS HAVING QUALITY ISSUES OF SOME SORT".

  Patient problems: Insufficient Information

  MAUDE report 17467438 ↗
• MalfunctionJun 29, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT DURING USE WITH BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR THE CONNECTOR WAS DAMAGED AND UNABLE TO UNSCREW OR TIGHTEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THE PRODUCT DID NOT PERFORM AS EXPECTED. THE CONNECTOR END IS VERY STIFF AND DIFFICULT TO UNSCREW/TIGHTEN, ESPECIALLY WITH ONE HAND AS IS REQUIRED WHEN STARTING AN IV. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: -DID THE EVENT INTERRUPT TREATMENT, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN TREATMENT, THAT NEGATIVELY IMPACTED THE PATIENT? IF YES, PLEASE PROVIDE DETAILS. YES, MULTIPLE IVS HAVE BEEN LOST IN THE PRE-OP AREA DUE TO J-LOOP FAILURE CAUSING ADDITIONAL IV STARTS/NEEDLE STICKS TO PATIENT AND DELAY OF SURGERY. IVS HAVE BEEN LOST IN A VARIETY OF OTHER AREAS AS WELL, CAUSING ADDITIONAL IV STICKS AND DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17234684 ↗
• MalfunctionMay 11, 2023Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT 4 OF THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR HAD A LOOSE CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT APPEARS THE BLUE HUB IS ATTACHED AT AN ANGLE/INSECURELY RATHER THAN SECURELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913742 ↗
• MalfunctionApr 20, 2023Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR MANIFOLD CONNECTION CAME LOOSE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS ANOTHER INSTANCE IN ENDO THAT THE MANIFOLD CONNECTION CAME LOOSE AND WAS LEAKING BUT DID NOT COME COMPLETELY APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16778913 ↗
• MalfunctionApr 20, 2023Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR EXPERIENCED LEAKAGE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WERE SEVERAL INSTANCES THAT THE EXTENSION TO THE ANGIOCATH WOULD BE LEAKING, AND THE NURSES HAD TO CHANGE THE DRESSING AND TIGHTEN THE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16778570 ↗
• MalfunctionApr 20, 2023Leak/Splash; Incomplete or Inadequate Connection; Leak/Splash; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR HAD A LOOSE CONNECTION TO THE ANGIO CATHETER, AND SPRAYED OUT MEDICATION ONTO THE PATIENT'S BACK AS A RESULT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE MANIFOLDS HAVE BEEN COMING APART AND LEAKING, AND THE CONNECTION WITH THE EXTENTION TO THE ANGIO SEEMS TO NOT SCREW ON VERY TIGHT AND LEAKS AT THAT SPOT. BD MAX PLUS PRESSURE RATED EXT SET - # MP5312-C NOT FULLY SECURING TO ANGIO CATH WHERE CIRCLED BELOW CAUSING LEAKAGE. DETAILS: PT. WAS IN ENDO BEING PUT TO SLEEP AND THE ANESTHESIA PROVIDER STATED THAT THE CONNECTION OF ITEM 7592897 TO THE ANGIO WAS LEAKING. HE TIGHTENED THAT CONNECTION THEN WENT TO THE MANIFOLD (7570763), STARTED GIVING PROPOFOL AND THE CONNECTION THERE CAME APART COMPLETELY AND SPRAYED THE PATIENT DOWN HER BACK. THERE WAS NO ADVERSE EVENT. IT JUST DELAYED THE PATIENT GETTING TO SLEEP FOR THE PROCEDURE. PROCEDURE: EGD AND COLONOSCOPY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16778545 ↗
• MalfunctionApr 3, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR HAD FLOW ISSUES DUE TO THE ANTI-REFLUX CAP BLOCKING FLUID DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ANTI REFLUX CAP (NC) PREVENTING ANYTHING FROM FLOWING THROUGH CONNECTOR INTO EXTENSION SET IT BLOCKS FLUID FLOW".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16670623 ↗
• MalfunctionDec 19, 2022Leak/Splash

  IT WAS REPORTED THAT 2 OF THE BD MAXPLUS¿ EXTENSION SET WERE LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RIGHT ABOVE THE CUFF AND WHERE THE TUBING ENTERS THE HARDER PLASTIC AREA IT WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005055 ↗
• MalfunctionSep 2, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED 8.5 IN PRESSURE RATED SET W/BONDED HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE BEEN HAVING THESE LEAK AT THE HUB WHERE ATTACHED TO IV TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418866 ↗