MaxGuard M4018Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403235740), received between Jul 6, 2020 and Nov 27, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Leak/Splash; Leak/Splash

  MATERIAL # M4018; BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THEY WERE INFUSING PROPOFOL THROUGH STOPCOCK, PORT STARTED LEAKING PROPOFOL. VERBATIM: M4018. RN WAS INFUSING PROPOFOL THROUGH STOPCOCK, PORT STARTED LEAKING PROPOFOL. RN STATES STOPCOCK WAS OPENED CORRECTLY. UNSURE HOW LONG PROPOFOL WAS INFUSING THROUGH TUBING AND STOPCOCK BEFORE THIS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20793148 ↗
• MalfunctionNov 22, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXGUARD STOPCOCK(S) WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. RN WAS INFUSING PROPOFOL THROUGH STOPCOCK, PORT STARTED LEAKING PROPOFOL. RN STATES STOPCOCK WAS OPENED CORRECTLY. UNSURE HOW LONG PROPOFOL WAS INFUSING THROUGH TUBING AND STOPCOCK BEFORE THIS OCCURRED. ADDITIONAL INFORMATION RECEIVED ON (B)(6). TWO INCIDENCES WERE REPORTED OF NURSING INFUSING PROPOFOL THROUGH THE TRI SMALLBORE TUBING EXTENSION SET (REF # (B)(4)): 1. EXACT DATES WERE THE WEEKEND OF (B)(6). 2. YES, WHEN THE NURSE DETACHED THE EXTENSION SET AND FLUSHED THE TUBING THERE WAS A NOTABLE WHOLE IN THE TUBING WHERE FLUID WAS INFUSING OUT OF. 3. YES, THE PATIENT STARTED TO WAKE UP AND ALMOST SELF EXTUBATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20760228 ↗
• MalfunctionNov 22, 2024Leak/Splash; Leak/Splash

  MATERIAL # M4018 BATCH # UNKNOWN IT WAS REPORTED BY CUSTOMER THAT THEY WERE INFUSING PROPOFOL THROUGH STOPCOCK, PORT STARTED LEAKING PROPOFOL. VERBATIM: M4018 RN WAS INFUSING PROPOFOL THROUGH STOPCOCK, PORT STARTED LEAKING PROPOFOL. RN STATES STOPCOCK WAS OPENED CORRECTLY. UNSURE HOW LONG PROPOFOL WAS INFUSING THROUGH TUBING AND STOPCOCK BEFORE THIS OCCURRED ADDITIONAL INFORMATION RECEIVED ON 05NOV TWO INCIDENCES WERE REPORTED OF NURSING INFUSING PROPOFOL THROUGH THE TRI SMALLBORE TUBING EXTENSION SET (REF # 20338E): 1. EXACT DATES WERE THE WEEKEND OF OCTOBER 24TH-26TH 2. YES, WHEN THE NURSE DETACHED THE EXTENSION SET AND FLUSHED THE TUBING THERE WAS A NOTABLE WHOLE IN THE TUBING WHERE FLUID WAS INFUSING OUT OF 3. YES, THE PATIENT STARTED TO WAKE UP AND ALMOST SELF EXTUBATED 4. NO 5. THERE IS A VIDEO THAT WAS INCLUDED IN THE ORIGINAL RL 6. UNABLE TO VERIFY LOT NUMBER AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759273 ↗
• MalfunctionDec 21, 2022Complete Blockage; Leak/Splash; Complete Blockage; Leak/Splash

  IT WAS REPORTED WHILE USING BD MAXGUARD STOPCOCK 4 WAY ROTARY LOCK LEAKAGE AND FLOW ISSUES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON FURTHER INSPECTION THIS RN NOTICED THE BED WAS WET. THE SPECIFIC BUFF CAP THAT THE LIPIDS WERE HOOKED UP TO WAS FOUND TO BE WET AND DRIPPING AND NO LIPIDS APPEARED TO BE MOVING FURTHER THAN THAT BUFF CAP. THE PT'S TPN/LIPIDS WERE HUNG AT 1700, SO PATIENT WAS WITHOUT FLUIDS FOR APPROXIMATELY 4 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16031086 ↗
• MalfunctionJul 6, 2020Backflow; Complete Blockage; Backflow; Complete Blockage

  IT WAS REPORTED THAT STOPCOCK 4 WAY ROTARY LOCK 25/BX HAD A BREAK IN THE FLUID PATH AND CAUSED BLOOD BACKFLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: M4018 BATCH(LOT) NO: 20045919 IT WAS REPORTED STOPCOCK CAUSING A BREAK IN THE FLUID PATH. WE HAVE HAD A COUPLE MORE INCIDENCES OF THE 4-WAY STOPCOCK BEING ATTACHED TO THE MICROCLAVE CONNECTOR AND CAUSING A BREAK IN THE FLUID PATH, RESULTING IN BLOOD ENTERING THE HOUSING AND NECESSITATING A CONNECTOR CHANGE. COULD YOU PLEASE VERIFY THE MATERIAL AND LOT # FOR THE PRODUCT? THE NUMBER YOU REFERENCED IN THE PREVIOUS EMAIL (10885403235740) IS TOO MANY NUMBERS. SORRY ABOUT THAT ¿ THE LOT IS 20045919. WHAT DAY AND TIME DID THE DEFECT OCCUR? FRI, JUNE 5TH AT 1600. WERE THERE ANY ADVERSE EFFECTS THAT OCCURRED DURING THE DEFECT? IF SO, PLEASE EXPLAIN. NO, NOT DIRECTLY; HOWEVER THE CONNECTOR NEEDED TO BE CHANGED RESULTING IN AN EXTRA OPENING OF THE CATHETER AND RISK OF INFECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10232635 ↗