MaxPlus MPX5304-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403237249), received between Oct 17, 2020 and Aug 23, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 18, 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.

• MalfunctionAug 23, 2023Complete Blockage; Complete Blockage

  ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: WAS THE TUBING SET ATTACHED TO A PATIENT AT THE TIME OF THE EVENT OR OCCURRED DURING PREPARATION/PRIMING? NO. WAS THE TUBING STILL COILED WITH TAPE IN PLACE DURING PRIMING/FLUSHING? UNKNOWN. WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607871 ↗
• MalfunctionJan 6, 2023Break; Break

  IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET TUBING CLAMP BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CLIPS KEEP BREAKING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117377 ↗
• MalfunctionOct 28, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WAS MISSING THE BLUE CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD MAX-PLUS PRESSURE RATE EXTENSION SET WITH CLEAR NEEDLELESS CONNECTOR AND Y-SITE: IT WAS MISSING THE BLUE CLAMP. I DID NOT USE IT ON THE PT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712638 ↗
• MalfunctionNov 12, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 11-IN EXTENSION SET W/ MAX Y AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: MPX5304-C; BATCH NO.: 20036111. IT WAS REPORTED THERE WAS A LEAK FROM THE T CONNECTOR. VERBATIM: IV TUBING LEAK FROM THE T CONNECTOR. IT IS POSSIBLE SOME PROPOFOL LEAKED FROM PATIENT'S IV LINE CAUSING LOOSE IV DRESSING. THIS WAS REPORTED DURING HAND OFF FROM RN TO PACU RN. NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10830684 ↗
• MalfunctionOct 17, 2020Backflow; Leak/Splash; Backflow; Leak/Splash

  IT WAS REPORTED THAT 11-IN EXTENSION SET W/ MAX Y AND DISCONNECTED AND THERE WAS BLOOD BACKFLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MPX5304-C BATCH NO: 20036111 IT WAS REPORTED THAT TUBING DISCONNECTED IN A JOINED AREA AND PATIENT WAS BLEEDING FROM WHAT WAS LEFT OF T-CONNECTOR. EVENT DESCRIPTION PER EMAIL STATES: T-CONNECTOR ATTACHED TO IV WAS DEFECTIVE. THE TUBING DISCONNECTED IN A JOINED AREA AND THE PT RANG BECAUSE HE WAS BLEEDING FROM WHAT WAS LEFT OF T-CONNECTOR. MINIMAL BLOOD LOSS AND A NEW INTACT T CONNECTOR ATTACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10694555 ↗