BD Vacutainer® Urine Complete Cup Kit 364957Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903649570), received between Jul 3, 2024 and May 21, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Short Fill” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 25, 2022Class IIOpen, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1617-2022 · Root cause: Environmental control · Recall details · FDA record ↗

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.

• MalfunctionMay 21, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® URINE COMPLETE CUP KIT, THE TUBES IN THE KIT WERE NOT DRAWING URINE INTO TUBES WITH GOOD VACUUM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25249513 ↗
• MalfunctionDec 1, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED WHILE USING ONE BD VACUTAINER® URINE COMPLETE CUP KIT, 1 PATIENT REPORTED THE TOWELETTE WAS DISCOLORED AND IS CONCERNED THAT IT WAS CONTAMINATED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23688041 ↗
• MalfunctionNov 10, 2025Microbial Contamination of Device; Device Ingredient or Reagent Problem; Microbial Contamination of Device; Device Ingredient or Reagent Problem

  IT WAS REPORTED DURING USE OF BD VACUTAINER® URINE COMPLETE CUP KIT, 15 TUBES ARE CONTAMINATED. THEY ARE SEEING MIXED GROWTH IN CULTURES. IN ADDITION, THE ADDITIVE LOOKS LIKE CONDENSATION. SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511632 ↗
• MalfunctionApr 25, 2025Off-Label Use; Short Fill; Expiration Date Error; Off-Label Use; Short Fill; Expiration Date Error

  IT WAS REPORTED WHILE USING BD VACUTAINER® URINE COMPLETE CUP KIT, UNDERFILL WAS OBSERVED IN AN UNSPECIFIED NUMBER OF DEVICES. IT WAS THEN DISCOVERED THAT THE EXPIRATION DATE ON THE SHELF LABEL WAS BEYOND THE EXPIRATION DATE OF THE TUBE. THE EXPIRATION DATE ON THE TUBE LABEL HAD ALREADY PASSED SO EXPIRED TUBES WERE USED. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21913518 ↗
• MalfunctionJul 3, 2024Short Fill; Device Ingredient or Reagent Problem; Short Fill; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® URINE COMPLETE CUP KIT AN UNSPECIFIED NUMBER OF TUBES HAD SIGNIFICANT CONDENSATION AND DID NOT FILL COMPLETELY. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19670238 ↗