BD UniVia 305851Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382903058518), received between Sep 19, 2019 and Sep 30, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (1 report).

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

• MalfunctionSep 30, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 3 SYRINGES ORAL 1ML CLEAR STERILE HAD DAMAGED STOPPERS FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGES WERE DAMAGED AROUND THE PLUNGER."

  Patient problems: No Patient Involvement

  MAUDE report 10610994 ↗
• MalfunctionSep 19, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE ORAL 1ML CLEAR STERILE THE COLOR OF THE PLUNGER CORRESPONDING TO BATCH: 9064913 IS DIFFERENT TO ALL PREVIOUS BATCHES. THERE ARE 100 UNITS THAT ARE AFFECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS OBSERVED THAT THE COLOR OF THE PLUNGER CORRESPONDING TO BATCH: 9064913 IS DIFFERENT TO ALL PREVIOUS BATCHES. IT IS LIGHTER AND OPAQUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9086830 ↗