MaxGuard ME1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403235948), received between May 14, 2019 and Jun 29, 2021 — classified as 1 injury, 4 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.

• MalfunctionJun 29, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 6 IN NON-DEHP MICROBORE BI-FUSE SET WAS DEFORMED/DAMAGED/CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: ME1001 BATCH NO.: 20126551. WHEN RN WENT TO HOOK UP IV TUBING TO PATIENT BY SCREWING THE BIFUSE (BD MAXGUARD BIFUSE EXTENSION SET) TO THE PATIENT'S PORT, THE BIFUSE LEUR LOCK CONNECTION COMPLETELY CRACKED DOWN THE MIDDLE. BIFUSE TUBING HAD TO BE REPLACED AS THIS WOULD NOT HAVE BEEN A CLEAN OR CLOSED SYSTEM IV TUBING FOR THE PATIENT ANYMORE, THEREFORE INCREASING HIS INFECTION RISK. IT ALSO WOULD HAVE CAUSED HIS IV FLUID TO LEAK AND THE IV TUBING TO BECOME DISCONNECTED FROM THE PORT IF THE CRACK WAS NOT NOTICED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089760 ↗
• MalfunctionJun 29, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 6 IN NON-DEHP MICROBORE BI-FUSE SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE HUB CRACKED WHILE REATTACHING IT TO THE PATIENT'S PICC LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089693 ↗
• InjuryJun 29, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 6 IN NON-DEHP MICROBORE BI-FUSE SET WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT LEAKING WAS NOTED ON BED SHEETS COMING FROM PICC TUBING. BLOOD BACKED UP INTO PICC EXTENSION AND INTO TUBING. UPON REMOVAL OF THE TUBING, THE BI-FUSE TUBING WAS NOTED TO BE CRACKED AT THE Y OF THE BI-FUSE EXTENSION PIECE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 12089632 ↗
• MalfunctionMar 17, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SCREW AT THE TOP OF THE 6 IN NON-DEHP MICROBORE BI-FUSE SET WAS CRACKED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 5TH OF 9 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SCREW TOP AT THE END OF THE BI-FUSE WAS FOUND TO BE CRACKED. NO LEAKING NOTICED, BUT WAS UNABLE TO GET A GOOD SEAL WHEN REATTACHING LINE TO PICC".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11508268 ↗
• MalfunctionMay 14, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE CUSTOMER REPORTED THAT THE TUBING CAME APART AND LEAKED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8610536 ↗