BD Vacutainer® Urinalysis Cup Kit 364989Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 50382903649896), received between Nov 27, 2017 and Aug 17, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 18, 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.

• MalfunctionAug 17, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A BD VACUTAINER® URINALYSIS CUP KIT CONTAINED TUBES THAT WERE CRUSHED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7793375 ↗
• MalfunctionJun 20, 2018Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT A BD VACUTAINER® URINALYSIS CUP KIT CONTAINED TUBES THAT WERE COLLAPSED. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7621726 ↗
• MalfunctionNov 27, 2017Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD VACUTAINER® URINE COLLECTION URINALYSIS CUP KIT: STERILE SCREW-CAP COLLECTION CUP WITH INTEGRATED TRANSFER DEVICE AND 8.0 ML, 16X100 MM PLUS PLASTIC CONICAL TUBE FOR URINALYSIS HAD A STOPPER COME OFF WHICH RESULTED IN A LEAK OF URINE INTO A BIOHAZARD BAG. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7059104 ↗