BD Vacutainer® Urinalysis Cup Kit 364946Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 50382903649469), received between Nov 27, 2017 and Aug 24, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Short Fill” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Incorrect, Inadequate or Imprecise Result or Readings; Microbial Contamination of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50418435 ↗
• MalfunctionNov 7, 2025Difficult to Insert; Short Fill; Difficult to Insert; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® URINALYSIS CUP KIT, THE NEEDLE BENDS WHEN INSERTING INTO THE TUBE AND THE TUBE UNDERFILLS IN AN UNSPECIFIED NUMBER OF KITS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496613 ↗
• MalfunctionJun 21, 2024Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® URINALYSIS CUP KIT AN UNSPECIFIED NUMBER OF TUBES WERE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19587410 ↗
• MalfunctionMay 10, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINALYSIS CUP KIT, THE DEVICE EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION ( ALL PACKAGING LEVEL). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT CUSTOMER REPORTS INCIDENTS WHERE "EXTRACTION DEVICE FOR THE URINE, SICKER WOULD GET PULLED OFF BY PATIENT OR JUST FALL OFF LEADING TO NEEDLE BEING EXPOSED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14349907 ↗
• MalfunctionMay 14, 2019Short Fill; Short Fill

  IT WAS REPORTED THAT UNDERFILL OCCURRED WITH KIT URINE CUP 16 X 100 8.0 CONI UAP RD/YEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE TUBES WITH THE URINE KIT'S CONSERVATOR DRAINS BELOW THE MINIMUM LINE. INFORMATION RECEIVED BY EMAIL ON 05/03/2019: IT WAS REPORTED AT LEAST 10 TUBES WITHOUT VACUUM. THEY DID NOT HAD ANY LOT NUMBER CHANGES (ALL AFFECTED PRODUCTS IS FROM THE SAME LOT NUMBER). THE TUBES IS STOCKED IN AMBIENT TEMPERATURE (ABOUT 8ºC AND 22ºC). THE CUSTOMER FOLLOW THE FABRICATOR INSTRUCTIONS TO PERFORM THE DRAINING.'' 4200 OCCURRENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8608105 ↗
• MalfunctionMay 8, 2019Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® COMPLETE URINE COLLECTION KIT IS UNDERFILLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBE IS FILLING THE MINIMUM VOLUME OF THE TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8593100 ↗
• MalfunctionOct 19, 2018Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT A BD VACUTAINER® COMPLETE URINE COLLECTION KIT HAD DEFORMED TUBES. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7985187 ↗
• MalfunctionAug 30, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 16MM X 100MM X 8ML BD VACUTAINER® PLUS PLASTIC COLLECTION KIT TOWELETTES CONTAINED FOREIGN MATTER DESCRIBED AS "BROWNISH APPEARANCE WITH DIRTINESS." NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7834921 ↗
• MalfunctionJul 18, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT 16MM X 100MM X 8ML BD VACUTAINER® PLUS PLASTIC COLLECTION KIT WAS YIELDING ERRONEOUS RESULTS. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7700531 ↗
• MalfunctionDec 1, 2017Leak/Splash

  IT WAS REPORTED THAT THE BD VACUTAINER® PLUS PLASTIC COLLECTION KIT LEAKED DURING TRANSPORT. NO INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7077392 ↗
• MalfunctionNov 27, 2017Crack; Hole In Material

  IT WAS REPORTED THAT THE 16MM X 100MM X 8ML BD VACUTAINER® PLUS PLASTIC COLLECTION KIT CUPS HAVE CRACKS AND/OR HOLES IN THEM. NO INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7059082 ↗