BD UniVia 305853Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382903058532), received between Jan 17, 2018 and Aug 18, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling 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.

• MalfunctionAug 18, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 8 BD¿ ORAL DISPENSING SYRINGE WAS DISCOVERED TO BE WITHOUT LABEL MARKERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3MLS ORAL SYRINGE HAS NO LABEL MARKERS ON THE SYRINGE. AT LEAST 8 FROM THE BATCH HAS NO LABELING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15250121 ↗
• MalfunctionAug 21, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT SYRINGE ORAL 3ML CLEAR STERILE WAS RECEIVED EXPIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED EXPIRED PRODUCT "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351921 ↗
• MalfunctionJan 17, 2018Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OCCURRED AT THE CONNECTION OF A 3 ML BD¿ ENTERAL SYRINGE WITH CLEAR BARREL AND BD UNIVIA¿ CONNECTOR. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7199496 ↗