BD UniVia 305855Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382903058556), received between Jan 17, 2018 and Jul 2, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 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.

• MalfunctionJul 2, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE SYRINGE ORAL 5ML CLEAR STERILE WAS INVOLVED WITH THE DEVICE OPERATOR EXPERIENCING GENERAL DISSATISFACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNFORTUNATELY OUR LAB GROUP IS RUNNING INTO ISSUES WITH THE OUTSIDE DIAMETERS ON TWO ENTERAL SYRINGES. OUR MEASUREMENTS ARE SHOWING THAT BOTH ARE OUT OF SPEC WITH THE OD TOO LARGE. SINCE THE PUMPS MEASURE THE OD AND USE IT TO DETERMINE WHAT SIZE SYRINGE IS LOADED THIS DISCREPANCY IS CAUSING ISSUES WITH THE PUMP'S ABILITY TO IDENTIFY THE SYRINGE. I SHOULD NOTE THIS IS SOMETHING WE'RE SEEING IN OUR LAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108096 ↗
• MalfunctionApr 10, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND AT AN UNSPECIFIED TIME WITH A 5 ML BD¿ ENTERAL SYRINGE WITH CLEAR BARREL & BD UNIVIA¿ CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "5ML SYRINGE WAS FOUND TO HAVE A SMALL CLEAR PLASTIC PIECE INSIDE THE BARREL OF THE SYRINGE ABOVE THE PLUNGER STOPPER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9950275 ↗
• MalfunctionJan 17, 2018Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OCCURRED AT THE CONNECTION OF A 5 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 7199501 ↗