MaxGuard MX5301Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10885403237553), received between Jan 9, 2020 and Apr 23, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Complete Blockage

  IT WAS REPORTED THAT THE BD MAXGUARD PRESSURE RATED EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOCKAGE ISSUES WERE IDENTIFIED ON OPENED ITEMS. INJURIES OR ADVERSE EVENT: NO, ITEM: MX5301, SERIAL/LOT NUMBER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974360 ↗
• MalfunctionApr 7, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE END THAT ATTACHES TO THE IV PRIMARY LINE CAME APART FROM THE TUBING.

  Patient problems: Insufficient Information

  MAUDE report 24802763 ↗
• MalfunctionFeb 26, 2026Infusion or Flow Problem

  NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462492 ↗
• MalfunctionFeb 11, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT THE BD MAXGUARD PRESSURE RATED EXTENSION SET HAD A LOOSE COMPONENT WITH A LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE FAILURE OCCURRED IN THE OR. THE SET WOULD NOT SEAL WHEN CONNECTED TO THE IV AND A LARGE AMOUNT OF BLOOD LEAKED. THERE WAS NO PATIENT OR EMPLOYEE HARM ASSOCIATED WITH THE OCCURRENCE. THIS HAPPENED WITH TWO SETS, BUT ONLY ONE WAS PRESERVED AS A SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317466 ↗
• MalfunctionNov 6, 2025Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS REPORTED THAT BD MAXGUARD PRESSURE RATED EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM EXTENSION SET SPLIT IN 2 AT NEEDLESS ACCESS WHEN RN WENT TO START IV. WAS ABLE TO SWITCH OUT EXTENSION AND EXTRA BLOOD LOSS WITH INCIDENT BUT MINIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23492898 ↗
• MalfunctionAug 9, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXGUARD PRESSURE RATED EXTENSION SET WITH Y-SITE WOULD NOT FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN FLUSHING IN AN ATTEMPT TO START AN IV THE NURSE NOTICED THE ITEM DID NOT FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494944 ↗
• MalfunctionJul 12, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD MAXGUARD PRESSURE RATED EXTENSION SET WITH Y-SITE THERE WAS A BLOCKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿I BELIEVE WE HAVE A BAD LOT OF THESE EXTENSIONS. THE FLUID WON'T FLUSH THROUGH THE EXTENSIONS WITH THIS LOT NUMBER.¿ ¿IC PULLED 3 PALLETS OF LN 474450 WITH LOT NUMBER 23039035.¿ LN 474450, SET EXT 8, LOT 23039035 THE HUNTSVILLE TEAM HAS PULLED 3 PALLETS OF THE SAME LOT # AND PUT TO THE SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313415 ↗
• MalfunctionJun 16, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD MAXGUARD¿ PRESSURE RATED EXTENSION SET WITH Y-SITE(S) 5 THE LINES ARE CLOGGED. THIS IS THE 1ST OF 2 COMPLAINTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD TROUBLE WITH THE NEW IV EXTENSION SETS SINCE WE SWITCHED TO THEM A FEW MONTHS AGO. THE BD MAXGUARD PRESSURE RATED EXTENSION SETS WORK MOST OF THE TIME, BUT THERE HAVE BEEN MULTIPLE INCIDENTS WHERE IVS WON'T RUN WELL OR FLUSH, WE ARE UNABLE TO BOLUS IV FLUID OR PUSH MEDS ON SOME OF THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148730 ↗
• MalfunctionMay 30, 2023Disconnection; Free or Unrestricted Flow; Disconnection; Free or Unrestricted Flow

  IT WAS REPORTED THAT THE BD MAXGUARD¿ PRESSURE RATED EXTENSION SET WITH Y-SITE(S) TUBING DISCONNECTED FROM THE Y-SITE DURING USE, ALLOWING BLOOD TO FREELY FLOW FROM THE IV SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AT THE YSITE, IT DISCONNECTED. THIS ALLOWED BLOOD TO FLOW FREELY FROM THE IV SITE AND THERE WASN'T A CLAMP ON THE PORTION STILL ATTACHED TO THE IV SITE TO STOP THE BLOOD FLOW. THIS CAUSED LOSS OF BLOOD AND RISK OF INFECTION TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17027041 ↗
• MalfunctionMay 3, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE BD MAXGUARD¿ PRESSURE RATED EXTENSION SET WITH Y-SITE(S) CAME APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "EXTENSION SET CAME APART"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865859 ↗
• MalfunctionApr 20, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT 2 BD MAXGUARD¿ PRESSURE RATED EXTENSION SET WITH Y-SITE(S) EXPERIENCED FLOW ISSUE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DESCRIBE THE EVENT OR PROBLEM: REGISTERED NURSE STARTING IV ON PATIENT WHO IS HERE THIS MORNING FOR SCHEDULED CESAREAN SECTION. IV PLACED ON RIGHT ARM WITHOUT DIFFICULTY, USED BD MAX GUARD PRESSURE RATED EXTENSION SET WITH NEEDLELESS Y SITE. ONCE CONNECTED TO IV LINE, BLOOD DRIPPING OUT OF THE CONNECTION PORT WHERE EXTENSION SET CONNECTS TO REGULAR IV TUBING. NURSE DOUBLE CHECKED CONNECTION MAKING SURE IT WAS TIGHTENED COMPLETELY AND CONTINUED TO LEAK. CARE WAS PAUSED TO REPLACE THE MAXGUARD EXTENSION SET, AND CURRENTLY APPEARS TO BE FUNCTIONING WITHOUT LEAKS. WE HAVE HAD 2 OTHER ISSUES WITH THIS SAME LOT NUMBER OF THESE BD MAXGUARD EXTENSION SETS. THE MANUFACTURERS HAVE REACHED OUT TO ME AND ASKED FOR THE SPECIFIC MALFUNCTIONING SITES, BUT THE NURSE DIDN'T COLLECT IT. THE OTHER EVENTS WERE REGARDING THESE EXTENSION SETS NOT FLOWING PROPERLY, BUT THEY DIDN'T LEAK. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : CESAREAN SECTION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781622 ↗
• MalfunctionApr 16, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BLOOD LEAKED OUT OF THE BD MAXGUARD¿ PRESSURE RATED EXTENSION SET WITH Y-SITE(S) CONNECTION PORT TO THE IV TUBING WHEN STARTING THE IV FOR THE C-SECTION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DESCRIBE THE EVENT OR PROBLEM: REGISTERED NURSE STARTING IV ON PATIENT WHO IS HERE THIS MORNING FOR SCHEDULED CESAREAN SECTION. IV PLACED ON RIGHT ARM WITHOUT DIFFICULTY, USED BD MAX GUARD PRESSURE RATED EXTENSION SET WITH NEEDLELESS Y SITE. ONCE CONNECTED TO IV LINE, BLOOD DRIPPING OUT OF THE CONNECTION PORT WHERE EXTENSION SET CONNECTS TO REGULAR IV TUBING. NURSE DOUBLE CHECKED CONNECTION MAKING SURE IT WAS TIGHTENED COMPLETELY AND CONTINUED TO LEAK. CARE WAS PAUSED TO REPLACE THE MAXGUARD EXTENSION SET, AND CURRENTLY APPEARS TO BE FUNCTIONING WITHOUT LEAKS... WE HAVE HAD 2 OTHER ISSUES WITH THIS SAME LOT NUMBER OF THESE BD MAXGUARD EXTENSION SETS. THE MANUFACTURERS HAVE REACHED OUT TO ME AND ASKED FOR THE SPECIFIC MALFUNCTIONING SITES, BUT THE NURSE DIDN'T COLLECT IT. THE OTHER EVENTS WERE REGARDING THESE EXTENSION SETS NOT FLOWING PROPERLY, BUT THEY DIDN'T LEAK. WHAT WAS TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748695 ↗
• MalfunctionJan 23, 2023Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE BD MAXGUARD¿ PRESSURE RATED EXTENSION SET WITH Y-SITE(S) IV HAD A LOOSE CONNECTION AND LEAKED DURING USE. THIS OCCURRED ONCE EACH IN LOTS 22099253 AND 22089181. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLUE CAP ON THE END HAS BEEN CHANGED TO A CLEAR CAP AND LEADING TO CONNECTION ISSUES, LEAKING OF IV'S, AND SEVERAL IV'S TO GO BAD... WAS THERE ANY PATIENT IMPACT OR PATIENT INVOLVEMENT? YES, LEAKAGE AROUND THE CAP AND/OR INABILITY TO REMOVE CAP WHICH RESULTS IN LOSS OF IV AND RESTICK FOR PATIENT. DID YOU EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THIS REPORTED DEFECT? HAVING TO RE INSERT SECOND IV ON PATIENTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16230703 ↗
• MalfunctionJul 13, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT 8-IN PRESSURE RATED EXTENSION SET WAS DIFFICULT TO DISCONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE SPIN ON THE MALE LEUR LOCK DOES NOT SECURE. VERBATIM: THE SPIN ON THE MALE LEUR LOCK DOES NOT SEEM TO SECURE. WHEN IT DOES SECURE, THE MALE LEUR IS ALMOST JAMMED IN TO THE IV CATHETER HUB AND AT TIMES CANNOT BE REMOVED BY HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12162957 ↗
• MalfunctionOct 30, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 8-IN PRESSURE RATED EXTENSION SET DISCONNECTED AT THE Y-SITE WHEN THE PATIENT TURNED IN BED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS HAD TWO EXTENSION SETS IN THE PAST WEEK DISCONNECT AT THE Y-SITE WITH A PATIENT TURNING IN THE BED. THE EXTENSION SET IN THE PICTURES WAS EASILY PULLED OFF WITHOUT GREAT EFFORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10766668 ↗
• MalfunctionJan 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED FROM THE PEDIATRIC EMERGENCY DEPARTMENT THAT THE PRESSURE RATED EXTENSION SET LEAKED AT THE CONNECTION TO THE TO THE IV HUB.

  Patient problems: No Information

  MAUDE report 9570084 ↗
• MalfunctionJan 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED FROM THE PEDIATRIC EMERGENCY DEPARTMENT THAT THE PRESSURE RATED EXTENSION SET LEAKED AT THE CONNECTION TO THE IV HUB.

  Patient problems: No Information

  MAUDE report 9570011 ↗
• MalfunctionJan 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED FROM THE PEDIATRIC EMERGENCY DEPARTMENT THAT THE PRESSURE RATED EXTENSION SET KINKED THE CATHETER AND LEAKED AT THE HUB.

  Patient problems: No Information

  MAUDE report 9569914 ↗