BD Vacutainer® Urinalysis Cup Kit 364981Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 50382903649810), received between Sep 25, 2019 and Apr 30, 2024 — classified as 5 malfunctions.

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

• MalfunctionApr 30, 2024

  BLUE TOP URINE SPECIMEN CUP SUCTION NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212717 ↗
• MalfunctionAug 31, 2020Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT THE TUBE UNDER FILLED DURING USE WITH A BD KIT URIN CUP PLC 16X100 10.0 UA YEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TUBE WAS NOT FILLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10471768 ↗
• MalfunctionJun 25, 2020Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT TUBE DOES NOT DRAW IN URINE WITH A BD KIT URIN CUP PLC 16X100 10.0 UA YEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS A PATIENT WHO RECEIVED THIS KIT. HE STATES THAT THE TUBE DOES NOT DRAW URINE INTO THE TUBE. KIT CONTAINED A ABSORBENT SLEEVE TO MAIL TUBE BACK IN AND HE WANTED TO KNOW HOW TO GET TUBE INTO SLEEVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10197255 ↗
• MalfunctionDec 27, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS OCCURRED WITH A BD KIT URIN CUP PLC 16X100 10.0 UA YEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) CUSTOMER DID AN EVALUATION FOR PRESERVATIVE UA TUBES VS NON PRESERVATIVE UA TUBE. CUSTOMER IS CONFUSED ABOUT THE METHOD COMPARISON. THEY BELIEVE THE METHOD COMPARISON SHOULD HAVE BETTER CORRELATION. THEY DO NOT UNDERSTAND THE METHOD IS A SIM-QUANTITATIVE METHOD. ADDITIONAL INFORMATION PROVIDED BY CUSTOMER: THE STUDY ON THE PROPOSED TUBES ON OUR EXISTING EQUIPMENT HAS BEEN COMPLETED. THE FOLLOWING WAS NOTICED ON THE STUDY. PROTEIN RESULTS ARE AFFECTED WHEN USING PRESERVATIVE CONTAINING TUBES (HIGHER VALUES OBTAINED), AND THE STUDY FAILED FOR THIS ANALYTE. LEUKOCYTE RESULTS ARE AFFECTED WHEN USING THE PRESERVATIVE CONTAINING TUBES (INCONSISTENCY ON THE LOW POSITIVES), AND THE STUDY FAILED FOR THIS ANALYTE. PH RESULTS ARE AFFECTED WHEN USING PRESERVATIVE CONTAINING TUBES (SLIGHTLY HIGHER VALUES OBTAINED ON %50 OF THE SPECIMENS), AND THE STUDY FAILED. CLARITY ON THE URINE WAS ALSO AFFECTED, AND VRMC HAS VALIDATED THE INSTRUMENT TO REPORT CLARITY DIRECTLY FROM ANALYZER. ALTHOUGH THIS ONE WAS NOT AS SIGNIFICANT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9527947 ↗
• MalfunctionSep 25, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT DURING USE THERE WAS ISSUE OF UNDER-FILLING WITH A BD KIT URIN CUP PLC 16X100 10.0 UA YEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER WAS EXPERIENCING DIFFICULTY USING AND/OR UNDER-FILLING OF VACUTAINER IN URINE COLLECTION KIT SENT BY CUSTOMER¿S INSURANCE COMPANY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9119341 ↗