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MaxGuard MX4457Recalls & reported problems

BD Switzerland Sàrl · 15 drop administration set, with 4 needleless Y-sites 374 cm (147 in) and 7.5" pressure rated extension set, (0.7 ml; 19.5 cm) · Class 2

All models of MaxGuard (49)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403237546), received between Jun 30, 2023 and Jul 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (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 16, 2026.

Most reported problems

Device problems

  • Complete Blockage2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 24, 2023Complete Blockage; Complete Blockage

    IT WAS REPORTED THAT THE BD IV ADMINISTRATION SETS WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM EMAILING REGARDING YESTERDAY¿S REPORT FORM PREOP THAT MANY OF THE IV TUBING SETS WERE FAULTY (THE FLUID WOULD NOT FLOW THROUGH THE EXTENSION SETS). WHEN XXX AND I LOOKED AT SEVERAL SETS AND TRIED THEM WE ALSO FOUND ONE THAT THE FLUID WOULD NOT FLOW ABOVE THE FILTER IN THE MAIN TUBING AS WELL. WE PULLED ALL THE TUBING WITH THAT PARTICULAR LOT NUMBER FOR RETURN TO BD AND A REPORT TO THE COMPANY. MY CONCERN IS: IF FLOW IS NOT GETTING THROUGH THE TUBING¿ IS IT STILL CONSIDERED STERILE? NOT SURE HOW THE STERILE PROCESS WORKS AND DOES GAS HAVE TO ALSO FLOW THROUGH THAT CHANNEL TO MAKE IT STERILE? SOME STAFF HAVE BEEN ABLE TO MAKE THE TUBING WORK BY BACK-FLUSHING OR FORCIBLY FLUSHING¿ I¿M CONCERNED THAT WE SHOULD NOT DO THIS IF IT IS NOT STERILE IN THE FLUID PATH."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17385985 ↗
  • MalfunctionJun 30, 2023Complete Blockage; Complete Blockage

    IT WAS REPORTED THAT 52 OF THE BD IV ADMINISTRATION SETS WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM EMAILING REGARDING YESTERDAY¿S REPORT FORM PREOP THAT MANY OF THE IV TUBING SETS WERE FAULTY (THE FLUID WOULD NOT FLOW THROUGH THE EXTENSION SETS). WHEN XXX AND I LOOKED AT SEVERAL SETS AND TRIED THEM WE ALSO FOUND ONE THAT THE FLUID WOULD NOT FLOW ABOVE THE FILTER IN THE MAIN TUBING AS WELL. WE PULLED ALL THE TUBING WITH THAT PARTICULAR LOT NUMBER FOR RETURN TO BD AND A REPORT TO THE COMPANY. MY CONCERN IS: IF FLOW IS NOT GETTING THROUGH THE TUBING. IS IT STILL CONSIDERED STERILE? NOT SURE HOW THE STERILE PROCESS WORKS AND DOES GAS HAVE TO ALSO FLOW THROUGH THAT CHANNEL TO MAKE IT STERILE? SOME STAFF HAVE BEEN ABLE TO MAKE THE TUBING WORK BY BACK-FLUSHING OR FORCIBLY FLUSHING¿ I¿M CONCERNED THAT WE SHOULD NOT DO THIS IF IT IS NOT STERILE IN THE FLUID PATH."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17239487 ↗

Other Set, administration, intravascular devices

All Set, administration, intravascular devices →

Sources and updates

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