BD UniVia 305857Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382903058570), received between Feb 20, 2019 and Feb 4, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Volume Accuracy Problem” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT 9000 BD ENTERAL SYRINGES HAD ILLEGIBLE SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " THE CUSTOMER INDICATES THAT THE SYRINGES HAVE A BLURRED SCALE IN THE INDICATED LOT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13455300 ↗
• MalfunctionJan 11, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD ENTERAL SYRINGE EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO OR HALF ERASED SCALE LINES ON THE INJECTOR. WE CANNOT SCALE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225973 ↗
• MalfunctionFeb 20, 2019Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE ORAL 10ML CLEAR STERILE EXPERIENCED LEAKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8354375 ↗