BD UniVia 305863Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903058631), received between Jan 17, 2018 and Nov 15, 2020 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2020Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THERE WERE NO SCALE MARKINGS ON THE SYRINGE ORAL 50ML CLEAR STERILE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE MARKINGS ON SYRINGE ARE MISSING." DATE: (B)(6) 2020 AT 3 PM, HARM: NO HARM, DEPARTMENT: NICU/SUPPLY CHAIN, REPORTED BY: RN, PRODUCT DESCRIPTION: BD 50 ML ORAL/ENTERAL SYRINGE. ENTERNAL FEEDING SYRINGE UTILIZED IN THE NICU.

  Patient problems: No Patient Involvement

  MAUDE report 10841528 ↗
• MalfunctionMay 15, 2020Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT SYRINGE ORAL 50ML CLEAR STERILE HAD NO SCALE MARKINGS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305863. BATCH NO: 9275383. IT WAS REPORTED THAT WHEN RN WAS PULLING HER SUPPLIES, IT WAS NOTICED THAT THERE NO VOLUME MARKINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10061402 ↗
• MalfunctionJun 19, 2018Fungus in Device Environment

  IT WAS REPORTED THAT THE BD¿ ENTERAL SYRINGE WITH CLEAR BARREL AND BD UNIVIA¿ CONNECTOR HAD WHAT LOOKS LIKE MOLD INSIDE THE BARREL. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7616381 ↗
• MalfunctionApr 24, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THERE WAS FOREIGN MATTER "SOME TYPE OF FUNGUS" FOUND ON THE TOP OF A BD¿ ENTERAL SYRINGE WITH CLEAR BARREL AND BD UNIVIA¿ CONNECTOR. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7455186 ↗
• MalfunctionJan 17, 2018Leak/Splash

  IT WAS REPORTED THAT A BD¿ ENTERAL SYRINGE WITH CLEAR BARREL AND BD UNIVIA¿ CONNECTOR LEAKED DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7201930 ↗