MaxPlus MP5310-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885403236686), received between Mar 12, 2019 and Mar 31, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 18, 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.

• MalfunctionMar 31, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT CONNECTED IV EXTENSION SET TUBING TWO PATIENTS IV BLOOD BEGAN TO SPURT AT THE SITE WHERE THE CLAVE WAS ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746541 ↗
• MalfunctionMar 31, 2026Crack; Fluid/Blood Leak

  ADDITIONAL EVENT DETAILS: EXTENSION SET WAS REMOVED AND ANOTHER ATTACHED THAT WORKED FINE. SAME LOT. UPON INSPECTION LOOKS LIKE THE CLAVE EITHER NOT THREADED STRAIGHT OUT OF PACKAGE OR MAYBE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746539 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak; Separation Problem

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING . IT WAS REPORTED BY CUSTOMER THAT THE BLOOD WAS LEAKING AROUND NEEDLESS CONNECTOR WHEN VACUTAINER WAS ATTACHED. NO BLOOD MADE ITS WAY INTO THE LAB BEAKER, IT ALL LEAKED OUT AROUND THE NEEDLELESS CONNECTOR SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492002 ↗
• MalfunctionMar 2, 2026Disconnection; Infusion or Flow Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490040 ↗
• MalfunctionFeb 28, 2025Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE SECOND IV EXTENSION TUBING DID NOT STAY ATTACHED TO THE IV HUB. THE PRIMARY RN REATTACHED AND CHANGED IV DRESSING EARLIER. LATER IN THE DAY SHE PAGED THE IV TEAM TO PLACE ANOTHER IV DUE TO LEAKING. WHEN ASSESSED, WE FOUND THE PIV HAD BLOOD RETURN AND FLUSHED FREELY AND THE IV TUBING WAS NOT TIGHTENING DONE ON THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21499403 ↗
• MalfunctionFeb 28, 2025Material Separation; Incomplete or Inadequate Connection; Material Separation; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DISCONNECTING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE SECOND IV EXTENSION TUBING DID NOT STAY ATTACHED TO THE IV HUB. THE PRIMARY RN REATTACHED AND CHANGED IV DRESSING EARLIER. LATER IN THE DAY SHE PAGED THE IV TEAM TO PLACE ANOTHER IV DUE TO LEAKING. WHEN ASSESSED, WE FOUND THE PIV HAD BLOOD RETURN AND FLUSHED FREELY AND THE IV TUBING WAS NOT TIGHTENING DONE ON THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21499402 ↗
• MalfunctionJul 9, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CAT SCAN, WHEN THE EXTENSION TUBING ATTACHED TO THE PERIPHERAL IV WAS FLUSHED AND THE SYRINGE REMOVED; BLOOD BACKED UP INTO THE TUBING AND LEAKED FROM THE NEEDLELESS VALVE. THE TUBING WAS REPLACED AND THE DRESSING WAS CHANGED. THE CUSTOMER STATES THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8773158 ↗
• MalfunctionMay 30, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE IV TEAM EXPERIENCED THE NEEDLELESS VALVE WAS NOT RETRACTING WHEN FLUSHED AFTER AN INFUSION AND BLOOD BACKED UP INTO THE TUBING.

  Patient problems: No Information

  MAUDE report 8656481 ↗
• MalfunctionMay 30, 2019Fluid/Blood Leak; Physical Resistance/Sticking; Fluid/Blood Leak; Physical Resistance/Sticking

  IT WAS REPORTED THAT FOLLOWING A CARDIZEM INFUSION THROUGH A PERIPHERAL IV, A NURSE IN THE EMERGENCY ROOM FLUSHED THE NEEDLELESS VALVE WITH SALINE AND EXPERIENCED BLOOD BACKING UP INTO THE EXTENSION TUBING AS THE INTERNAL PISTON REMAINED DEPRESSED WHEN THE SYRINGE WAS DISCONNECTED. THIS PRODUCT HAD BEEN IN USE FOR TWENTY FOUR HOURS. THE CUSTOMER STATES THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8656084 ↗
• MalfunctionApr 28, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE MAXPLUS¿ NEEDLESS CONNECTOR ON THE PRESSURE RATED EXTENSION SET LEAKED AT THE CONNECTION TO THE BD AUTO GUARD PERIPHERAL IV SITE.

  Patient problems: No Information

  MAUDE report 8559626 ↗
• MalfunctionMar 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "THE IV LOOP "MAXPLUS PRESSURE RATED EXTENSION SET WITH CLEAR NEEDLELESS CONNECTOR" HAS A SMALL BLUE PIECE THAT RECOILS TO CLOSE THE IV CONNECTION AND KEEP PRESSURE IN THE TUBING. WHEN DISCONNECTING LURE LOCK SYRINGES OF ANY KIND THE BLUE PIECE WILL INCONSISTENTLY STAY DEPRESSED, ALLOWING FOR FLUIDS/BLOOD TO LEAK BACK OUT OF THE TUBE. A PATIENT COULD LOSE A SIGNIFICANT AMOUNT OF BLOOD IF THIS WERE TO GO UNNOTICED." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED. THIS OCCURRED IN THE EMERGENCY DEPARTMENT AND THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8412071 ↗