MaxPlus MP5314-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10885403236723), received between Aug 3, 2021 and Aug 17, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (10 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280932 ↗
• MalfunctionAug 17, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280896 ↗
• MalfunctionAug 17, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280895 ↗
• MalfunctionMar 3, 2026Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT LEAKED AT IV CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24503164 ↗
• MalfunctionJan 8, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT HAD TWO PATIENTS OVER THE WEEKEND OF 12/13-12/14 WHOSE J-LOOPS CAME DETACHED FROM THE IV CATHETER PORT WHILE THE PATIENTS WERE IN POSTPARTUM. THIS MORNING 12/15, ONE OF OUR INDUCTIONS ALSO HAD THEIRS BECOME DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016280 ↗
• MalfunctionJan 8, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS SEPARATEDTHE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIMIT WAS REPORTED BY THE CUSTOMER THAT HAD TWO PATIENTS OVER THE WEEKEND OF 12/13-12/14 WHOSE J-LOOPS CAME DETACHED FROM THE IV CATHETER PORT WHILE THE PATIENTS WERE IN POSTPARTUM. THIS MORNING 12/15, ONE OF OUR INDUCTIONS ALSO HAD THEIRS BECOME DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016279 ↗
• MalfunctionJan 8, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT HAD TWO PATIENTS OVER THE WEEKEND ON (B)(6) WHOSE J-LOOPS CAME DETACHED FROM THE IV CATHETER PORT WHILE THE PATIENTS WERE IN POSTPARTUM. THIS MORNING ON (B)(6), ONE OF OUR INDUCTIONS ALSO HAD THEIRS BECOME DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016277 ↗
• MalfunctionDec 11, 2025Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE NURSE ATTEMPTED TO APPLY THE EXTENSION SET PER PROTOCOL. WHEN THEY WAS SECURING THE EXTENSION DEVICE TO THE INT CATHETER, IT WOULD NOT COMPLETELY SEAL. THIS ALLOWED BLOOD TO CONTINUE TO FLOW AND POOL UNDER THE PT'S ELBOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783985 ↗
• MalfunctionDec 3, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THEY CANNOT SCREW THE PRODUCT ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23710733 ↗
• MalfunctionDec 3, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THEY EXPERIENCED CONNECTION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23710732 ↗
• MalfunctionOct 20, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET HAD A LOOSE COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A ROUTINE IV INSERTION WAS COMPLETED ON THIS PATIENT AT 2125 USING THE 'BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE CLEAR NEEDLELESS CONNECTOR' TO CONNECT TO THE INT. I PAID EXTRA ATTENTION TO TIGHTENING THE CONNECTOR TO THE INT BECAUSE THE RAD TECH WAS AT BEDSIDE WAITING TO TAKE THE PATIENT FOR A CT SCAN WITH CONTRAST. IT IS COMMON FOR THESE EXTENSION SETS TO COME LOOSE DURING CONTRAST ADMINISTRATION IN CT SCAN. TECH CALLED ME AFTER PERFORMING HER TEST INJECTION FOR THE CT SCAN WITH THE AUTO INJECTOR BECAUSE THE PATIENT WAS BLEEDING SIGNIFICANTLY FROM HIS IV. I FOUND THE SCREWING PORTION OF THIS EXTENSION SET COMPLETELY LOOSE AND THE EXTENSION SET WAS OUT OF THE INT HUB ALLOWING THE PATIENT TO FREE BLEED. I REAPPLIED THE EXTENSION SET AND SCREWED IT AS TIGHTLY AS POSSIBLE, CLEANED UP THE PATIENT, AND REAPPLIED A SECURE DRESSING. WHEN RETURNING TO MY DEPARTMENT I RECEIVED ANOTHER CALL FROM RADIOLOGY THAT THE INT IS LEAKING AGAIN WITH THE AUTOINJECTOR TEST FLUSH. I CHANGED THIS EXTENSION SET OUT WITH A NEW ONE AND WE WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337168 ↗
• MalfunctionOct 16, 2025Connection Problem; Separation Problem; Connection Problem; Separation Problem

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET HAD SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A ROUTINE IV INSERTION WAS COMPLETED ON THIS PATIENT AT 2125 USING THE 'BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE CLEAR NEEDLELESS CONNECTOR' TO CONNECT TO THE INT. I PAID EXTRA ATTENTION TO TIGHTENING THE CONNECTOR TO THE INT BECAUSE THE RAD TECH WAS AT BEDSIDE WAITING TO TAKE THE PATIENT FOR A CT SCAN WITH CONTRAST. IT IS COMMON FOR THESE EXTENSION SETS TO COME LOOSE DURING CONTRAST ADMINISTRATION IN CT SCAN. (B)(6) CALLED ME AFTER PERFORMING HER TEST INJECTION FOR THE CT SCAN WITH THE AUTO INJECTOR BECAUSE THE PATIENT WAS BLEEDING SIGNIFICANTLY FROM HIS IV. I FOUND THE SCREWING PORTION OF THIS EXTENSION SET COMPLETELY LOOSE AND THE EXTENSION SET WAS OUT OF THE INT HUB ALLOWING THE PATIENT TO FREE BLEED. I REAPPLIED THE EXTENSION SET AND SCREWED IT AS TIGHTLY AS POSSIBLE, CLEANED UP THE PATIENT, AND REAPPLIED A SECURE DRESSING. WHEN RETURNING TO MY DEPARTMENT I RECEIVED ANOTHER CALL FROM RADIOLOGY THAT THE INT IS LEAKING AGAIN WITH THE AUTOINJECTOR TEST FLUSH. I CHANGED THIS EXTENSION SET OUT WITH A NEW ONE AND WE WERE ABLE

  Patient problems: Pain

  MAUDE report 23312269 ↗
• MalfunctionOct 16, 2025Connection Problem; Separation Problem; Connection Problem; Separation Problem

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET HAD SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A ROUTINE IV INSERTION WAS COMPLETED ON THIS PATIENT AT 2125 USING THE 'BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE CLEAR NEEDLELESS CONNECTOR' TO CONNECT TO THE INT. I PAID EXTRA ATTENTION TO TIGHTENING THE CONNECTOR TO THE INT BECAUSE THE RAD TECH WAS AT BEDSIDE WAITING TO TAKE THE PATIENT FOR A CT SCAN WITH CONTRAST. IT IS COMMON FOR THESE EXTENSION SETS TO COME LOOSE DURING CONTRAST ADMINISTRATION IN CT SCAN. (B)(6) CALLED ME AFTER PERFORMING HER TEST INJECTION FOR THE CT SCAN WITH THE AUTO INJECTOR BECAUSE THE PATIENT WAS BLEEDING SIGNIFICANTLY FROM HIS IV. I FOUND THE SCREWING PORTION OF THIS EXTENSION SET COMPLETELY LOOSE AND THE EXTENSION SET WAS OUT OF THE INT HUB ALLOWING THE PATIENT TO FREE BLEED. I REAPPLIED THE EXTENSION SET AND SCREWED IT AS TIGHTLY AS POSSIBLE, CLEANED UP THE PATIENT, AND REAPPLIED A SECURE DRESSING. WHEN RETURNING TO MY DEPARTMENT I RECEIVED ANOTHER CALL FROM RADIOLOGY THAT THE INT IS LEAKING AGAIN WITH THE AUTOINJECTOR TEST FLUSH. I CHANGED THIS EXTENSION SET OUT WITH A NEW ONE AND WE WERE ABLE

  Patient problems: Pain

  MAUDE report 23312043 ↗
• MalfunctionOct 16, 2025Connection Problem; Separation Problem; Connection Problem; Separation Problem

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET HAD SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A ROUTINE IV INSERTION WAS COMPLETED ON THIS PATIENT AT 2125 USING THE 'BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE CLEAR NEEDLELESS CONNECTOR' TO CONNECT TO THE INT. I PAID EXTRA ATTENTION TO TIGHTENING THE CONNECTOR TO THE INT BECAUSE THE RAD TECH WAS AT BEDSIDE WAITING TO TAKE THE PATIENT FOR A CT SCAN WITH CONTRAST. IT IS COMMON FOR THESE EXTENSION SETS TO COME LOOSE DURING CONTRAST ADMINISTRATION IN CT SCAN. (B)(6) CALLED ME AFTER PERFORMING HER TEST INJECTION FOR THE CT SCAN WITH THE AUTO INJECTOR BECAUSE THE PATIENT WAS BLEEDING SIGNIFICANTLY FROM HIS IV. I FOUND THE SCREWING PORTION OF THIS EXTENSION SET COMPLETELY LOOSE AND THE EXTENSION SET WAS OUT OF THE INT HUB ALLOWING THE PATIENT TO FREE BLEED. I REAPPLIED THE EXTENSION SET AND SCREWED IT AS TIGHTLY AS POSSIBLE, CLEANED UP THE PATIENT, AND REAPPLIED A SECURE DRESSING. WHEN RETURNING TO MY DEPARTMENT I RECEIVED ANOTHER CALL FROM RADIOLOGY THAT THE INT IS LEAKING AGAIN WITH THE AUTOINJECTOR TEST FLUSH. I CHANGED THIS EXTENSION SET OUT WITH A NEW ONE AND WE WERE ABLE

  Patient problems: Pain

  MAUDE report 23312042 ↗
• MalfunctionOct 16, 2025Connection Problem; Separation Problem; Connection Problem; Separation Problem

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET HAD SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A ROUTINE IV INSERTION WAS COMPLETED ON THIS PATIENT AT 2125 USING THE 'BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE CLEAR NEEDLELESS CONNECTOR' TO CONNECT TO THE INT. I PAID EXTRA ATTENTION TO TIGHTENING THE CONNECTOR TO THE INT BECAUSE THE RAD TECH WAS AT BEDSIDE WAITING TO TAKE THE PATIENT FOR A CT SCAN WITH CONTRAST. IT IS COMMON FOR THESE EXTENSION SETS TO COME LOOSE DURING CONTRAST ADMINISTRATION IN CT SCAN. (B)(6) CALLED ME AFTER PERFORMING HER TEST INJECTION FOR THE CT SCAN WITH THE AUTO INJECTOR BECAUSE THE PATIENT WAS BLEEDING SIGNIFICANTLY FROM HIS IV. I FOUND THE SCREWING PORTION OF THIS EXTENSION SET COMPLETELY LOOSE AND THE EXTENSION SET WAS OUT OF THE INT HUB ALLOWING THE PATIENT TO FREE BLEED. I REAPPLIED THE EXTENSION SET AND SCREWED IT AS TIGHTLY AS POSSIBLE, CLEANED UP THE PATIENT, AND REAPPLIED A SECURE DRESSING. WHEN RETURNING TO MY DEPARTMENT I RECEIVED ANOTHER CALL FROM RADIOLOGY THAT THE INT IS LEAKING AGAIN WITH THE AUTOINJECTOR TEST FLUSH. I CHANGED THIS EXTENSION SET OUT WITH A NEW ONE AND WE WERE ABLE

  Patient problems: Pain

  MAUDE report 23312033 ↗
• MalfunctionAug 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT MAXPLUS PRESSURE RATED EXTENSION SET WAS DISCONNECTING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT WHEN INJECTING THE CONTRAST WITH THE AUTO INJECTOR THAT MANY TIMES THE EXTENSION SET WAS DISCONNECTING FROM THE IV CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22886523 ↗
• MalfunctionJan 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT LEAKING AT THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223849 ↗
• MalfunctionSep 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD EXTENSION SET SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: VERBATIM: BD MAX PLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE CLEAR NEEDLESS CONNECTOR WOULD NOT CONNECT TO IV HUB CAUSING BLOOD TO LEAK OUT AROUND THE CONNECTOR. ISSUE RESOLVED WHEN CHANGED TO SUB ITEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201016 ↗
• MalfunctionJun 10, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NURSES ARE SAYING THAT THE LL CONNECTOR PIECE THAT TURNS TO ATTACH TO THE IV IS VERY HARD TO TURN THIS RESULTS IN SOMETIMES NOT GETTING IT ATTACHED PROPERLY. THEY THINK IT IS BUT THEN IT LEAKS AND THEY HAVE A BLOODY MESS TO DEAL WITH, EVEN WORSE THE PATIENT SEES IT AND GETS WORRIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19507019 ↗
• MalfunctionJul 15, 2023Leak/Splash; Incomplete or Inadequate Connection; Leak/Splash; Incomplete or Inadequate Connection

  IT WAS REPORTED, THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD MAXPLUS¿ PRESSURE RATED EXTENSION SET. WITH REMOVABLE NEEDLELESS CONNECTOR, THERE WAS A POOR CONNECTION AND LEAKAGE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR SURGERY AREA IS SEEING AN ISSUE WITH THE BD MAXPLUS PRODUCT REF#: MP314-C. SEEMS TO HAVE A LEAK /SEAL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17330473 ↗
• MalfunctionJun 7, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR WAS MISSING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MTM2 FOUND EXTENSION SET MISSING ONE OF THE ENDS DURING PRODUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17081232 ↗
• MalfunctionMar 9, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR CAUSED BLOOD EXPOSURE TO THE STAFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ANY MEDICAL INTERVENTION/ OR TREATMENT DUE TO REPORTED ISSUE? NO TREATMENT- MORE BLOOD EXPOSURE TO STAFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16510610 ↗
• MalfunctionDec 20, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR TUBING WAS BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE TUBING IS BLOCKED SOMEHOW-BRAND NEW BUT CANNOT GET ANYTHING TO GO THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018925 ↗
• MalfunctionDec 1, 2022Obstruction of Flow

  THE TUBING IS BLOCKED SOMEHOW-BRAND NEW BUT CANNOT GET ANYTHING TO GO THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15892947 ↗
• MalfunctionNov 7, 2022No Flow

  TUBING IS BLOCKED, NO LIQUID WILL FLOW THROUGH.

  Patient problems: Insufficient Information

  MAUDE report 15742800 ↗