MaxPlus MP5301-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 10885403236600), received between Apr 18, 2019 and Sep 28, 2026 — classified as 1 injury, 126 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (60 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 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918132 ↗
• MalfunctionSep 25, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906082 ↗
• MalfunctionSep 25, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906081 ↗
• MalfunctionSep 25, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906080 ↗
• MalfunctionSep 25, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906079 ↗
• MalfunctionMay 12, 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 IV BEGAN LEAKING CONTRAST, AND THE TUBING THAT IS PERMANENTLY ATTACHED INTO THE HUB BROKE OFF AND CAME OUT OF THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153064 ↗
• MalfunctionMay 12, 2026Leak/Splash; Separation Failure

  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 IV BEGAN LEAKING CONTRAST, AND THE TUBING THAT IS PERMANENTLY ATTACHED INTO THE HUB BROKE OFF AND CAME OUT OF THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153062 ↗
• MalfunctionMay 7, 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 CUSTOMER THAT THE PLASTIC HUB IS DIFFICULT TO SCREW ON TO CONNECT TO THE IV CATHETER, RESULTING IN LEAKING IVS DUE TO INABILITY TO PROPERLY SECURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116384 ↗
• MalfunctionMay 7, 2026Connection 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 CUSTOMER THAT THE PLASTIC HUB IS DIFFICULT TO SCREW ON TO CONNECT TO THE IV CATHETER, RESULTING IN LEAKING IVS DUE TO INABILITY TO PROPERLY SECURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116382 ↗
• MalfunctionMar 30, 2026Leak/Splash; Separation Failure

  IT WAS REPORTED 8.5 IN PRESSURE RATED SET W/BONDED, SEPARATED. ADDITIONAL INFORMATION: WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? DURING THE USE WHILE THE PATIENT WAS ON 2D ON 2.23. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO, LINE WAS REMOVED AND REPLACED WAS THERE ANY LEAKAGE? YES, ITEM WAS LEAKING DURING RRT WHEN STAFF FLUSHED LINE TO ADMINISTER MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729078 ↗
• MalfunctionMar 16, 2026Connection 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 CUSTOMER THAT LUER ON NEEDLESS CONNECTOR EXTENSION TUBING IS GETTING STUCK AND NOT LURING CAUSING LEAKING DELAYS IN PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604934 ↗
• MalfunctionJan 26, 2026Material Separation

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE AN RN WAS STARTING AN IV A PIECE OF THE SALINE LOCK BROKE OFF. PRODUCT THAT MALFUNCTIONED? REFERENCE#: MP5301-C, LOT#: 25105490. WHAT WAS THE ISSUE? WHILE AN RN WAS STARTING AN IV A PIECE OF THE SALINE LOCK BROKE OFF. WERE THERE ANY PATIENT INJURIES? NO. WERE THERE ANY EMPLOYEE INJURIES? NO. WAS THERE ANY DELAY IN PATIENT TREATMENT? NONE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178883 ↗
• MalfunctionDec 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT BD MAXZERO 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 THE EXTENSION SET WILL DETACH FROM IV CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860635 ↗
• MalfunctionOct 19, 2025Failure to Disconnect; Failure to Disconnect

  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: IT WAS REPORTED BY THE CUSTOMER THAT WHEN REMOVING THE IV TUBING FROM THE EXTENSION SET AFTER THE PATIENT'S ANTIBIOTICS FINISHED THE TIP OF THE IV TUBING BROKE OFF IN THE EXTENSION SET. THE IV TUBING BECOME STUCK IN THE EXTENSION SET. FAIRLY COMMON FOR STAFF TO HAVE DIFFICULTY REMOVING IV TUBING FROM THE EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23333603 ↗
• MalfunctionOct 19, 2025Material Puncture/Hole; Infusion or Flow Problem; Material Puncture/Hole; Infusion or Flow Problem

  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 CUSTOMER THAT PIV EXTENSION TUBING WAS CRACKED AT THE NEEDLE FREE LUMEN CAUSING BACKFLOW OF BLOOD ONCE ATTACHED TO PIV HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23333567 ↗
• MalfunctionSep 15, 2025Detachment of Device or Device Component

  THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH CLEAR NEEDLESS ADAPTER COME APART FROM THE IV CATHETER AT THE LUER LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050880 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD MAXPLUS EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE EXTENSION TUBING COMING LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206399 ↗
• MalfunctionJun 12, 2025Device Damaged Prior to Use; Free or Unrestricted Flow; Device Damaged Prior to Use; Free or Unrestricted Flow

  IT WAS REPORTED THAT BD MAXPLUS EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE PINCH CLAMP DID NOT WORK PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196054 ↗
• MalfunctionApr 23, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT IN 3 OF THE EVENTS, THE CLAMP WAS ENGAGED ON THE EXTENSION SET MP5301-C BETWEEN THE PRIMARY TUBING 2420-0007 AND THE VASCULAR ACCESS DEVICE. IT HAS HAPPENED ON BOTH PERIPHERAL AND CENTRAL LINES. BOTH HAVE THE MP5301-C CONNECTED. THIS EXTENSION SET HAS NOT BEEN SENT IN YET, BUT THE LAST EVENT OF FAILURE TO ALARM FOR AN OCCLUSION ON (B)(6) 2025, HAS THE EXTENSION SET STILL ATTACHED. ON THE 4TH EVENT, THE ROLLER CLAMP ON THE PRIMARY SET WAS SAID TO BE ENGAGED. ALL WERE DELIVERED AS PRIMARIES. IN EACH CASE THE INFUSION DID NOT COMPLETE AND HAD TO BE REPROGRAMMED AFTER THE CLAMP WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896716 ↗
• MalfunctionApr 23, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT IN 3 OF THE EVENTS, THE CLAMP WAS ENGAGED ON THE EXTENSION SET MP5301-C BETWEEN THE PRIMARY TUBING 2420-0007 AND THE VASCULAR ACCESS DEVICE. IT HAS HAPPENED ON BOTH PERIPHERAL AND CENTRAL LINES. BOTH HAVE THE MP5301-C CONNECTED. THIS EXTENSION SET HAS NOT BEEN SENT IN YET, BUT THE LAST EVENT OF FAILURE TO ALARM FOR AN OCCLUSION ON (B)(6) 2025, HAS THE EXTENSION SET STILL ATTACHED. ON THE 4TH EVENT, THE ROLLER CLAMP ON THE PRIMARY SET WAS SAID TO BE ENGAGED. ALL WERE DELIVERED AS PRIMARIES. IN EACH CASE THE INFUSION DID NOT COMPLETE AND HAD TO BE REPROGRAMMED AFTER THE CLAMP WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896674 ↗
• MalfunctionApr 23, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT IN 3 OF THE EVENTS, THE CLAMP WAS ENGAGED ON THE EXTENSION SET MP5301-C BETWEEN THE PRIMARY TUBING 2420-0007 AND THE VASCULAR ACCESS DEVICE. IT HAS HAPPENED ON BOTH PERIPHERAL AND CENTRAL LINES. BOTH HAVE THE MP5301-C CONNECTED. THIS EXTENSION SET HAS NOT BEEN SENT IN YET, BUT THE LAST EVENT OF FAILURE TO ALARM FOR AN OCCLUSION ON 03/24/2025, HAS THE EXTENSION SET STILL ATTACHED. ON THE 4TH EVENT, THE ROLLER CLAMP ON THE PRIMARY SET WAS SAID TO BE ENGAGED. ALL WERE DELIVERED AS PRIMARIES. IN EACH CASE THE INFUSION DID NOT COMPLETE AND HAD TO BE REPROGRAMMED AFTER THE CLAMP WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896673 ↗
• MalfunctionApr 17, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS NOT BEING ABLE TO USE MAXPLUS MP5301-C EXTENSION SET FOR GRAVITY INFUSION. CUSTOMER IS PLACING THE INTRACANAL IV CATHETER AND CONNECTING IT TO THE MAX PLUS EXTENSION SET. CUSTOMER STATES THAT SOMETIMES THEY ARE UNABLE TO GET THE FLUID TO FLOW IN VIA GRAVITY. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: 1. KINDLY PROVIDE THE BATCH/LOT NUMBER OF THE PRODUCT. THE LOT NUMBER OF OUR CURRENT SHIPMENT IS (10)24119189. WHEN I ASKED OUR BUYER IF THERE WERE OTHER LOT NUMBERS SHE ADVISED ME OF ONLY OUR CURRENT LOT NUMBER. 2. KINDLY PROVIDE THE DATE OF EVENT. THERE HAVE BEEN MULTIPLE DATES, ALL HAVE BEEN IN THE LAST SEVERAL MONTHS. 3. CAN YOU SHARE ANY PHYSICAL SAMPLE OR PHOTO IF AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? I DO NOT HAVE A SAMPLE OF THE NONFUNCTIONING EXTENSION. THEY HAD BEEN USED AND DISPOSED OF. NO PHOTOS WERE TAKEN. 4. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860102 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT; DEVICE CAME APART JUST ABOVE THE LOCKING COLLAR WHILE CONNECTED TO A CONTRAST POWER INJECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698670 ↗
• MalfunctionMar 26, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. ARE YOU ABLE TO HELP ME SEND A PRODUCT COMPLAINT TO BD REGARDING THIS IV EXTENSION THAT BROKE APART DURING A CT CONTRAST INJECTION? THE NURSE SAID IT BLEW APART AND CONTRAST WAS SPRAYING AROUND THE ROOM. THIS OCCURRED LATE WEDNESDAY NIGHT, 2/26. I CHECKED WITH THE CT STAFF AND THEY TOLD ME CONTRAST FOR THAT TYPE OF TEST FLOWS AT 4.5 ML PER SECOND WITH A PRESSURE LIMIT OF 300 PSI¿WHICH THIS DEVICE IS RATED FOR 10 ML PER SEC AND 325 PSI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697881 ↗
• MalfunctionDec 10, 2024Material Separation; Material Separation

  MATERIAL: MP5301-C, BATCH#: 24089224, 24089191. IT WAS REPORTED BY THE CUSTOMER THAT HAD 2 IV TUBING MALFUNCTIONS: THE FIRST WAS A PIGTAIL AND THE SECOND IS PRIMARY TUBING. BOTH HAD THE END CAP DISCONNECT SPONTANEOUSLY:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895901 ↗