BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COLLECTION CUPS

    MDR report key: 9940411 · Received April 8, 2020

    Report

    Report Number
    1917413-2020-00370
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 19, 2020
    Report Date
    June 1, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    KDT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE CORRECTED WITH ADDITIONAL INFORMATION: D.4. DEVICE MATERIAL NUMBER: 364975; UDI NUMBER: (B)(4). D.2. TYPE OF DEVICE: KDT; COMMON DEVICE NAME: SPECIMEN TRANSPORT AND STORAGE CONTAINED. D.1. BD VACUTAINER® URINE COLLECTION CUPS. G.5. 510K NUMBER: EXEMPT. B.5. EVENT DESCRIPTION: IT WAS REPORTED THAT BD VACUTAINER® URINE COLLECTION CUPS WERE LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE ARE LEAKY URINE CUPS AND THE PRODUCT IS FLIMSY. SPECIAL CIRCUMSTANCES HAVE PROMPTED STANFORD MEDICAL DIRECTOR TO HAVE ALL PRIMARY CUPS OUR BLUE CUP BE SENT TO THE LAB WITH THE TUBES. SINCE IMPLEMENTATION, THEY HAVE NOTICED THAT THERE'S A LOT OF LEAKAGE ON OUR CUPS. 4-5 SAMPLES PER 10. THEY DO A LOT OF TESTING AND MENTIONED TO US IT'S A FLAW IN THE DESIGN OF THE CUP. EVEN SHORT SAMPLES ARE LEAKING AND LOSING ALL THE SAMPLES. THERE ARE SPECIAL TESTS THEY HAVE TO SEND TO ONE OF THEIR OFFSITE LAB AND THEY HAD TO USE PARAFIM TO SEAL THE LID AND STILL LEAKS AFTER IT GETS TO THE OTHER STANFORD LAB. PREVIOUS REP MENTIONED THAT THIS IS NOT THE FIRST TIME A PIR WAS SUBMITTED. THEY COMMENTED OUR CUPS ARE TOO FLIMSY AND NO MATTER HOW GOOD THEY TIGHTEN IT, IT STILL LEAKS,".

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® URINE COLLECTION CUPS WERE LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE ARE LEAKY URINE CUPS AND THE PRODUCT IS FLIMSY. SPECIAL CIRCUMSTANCES HAVE PROMPTED STANFORD MEDICAL DIRECTOR TO HAVE ALL PRIMARY CUPS OUR BLUE CUP BE SENT TO THE LAB WITH THE TUBES. SINCE IMPLEMENTATION, THEY HAVE NOTICED THAT THERE'S A LOT OF LEAKAGE ON OUR CUPS. 4-5 SAMPLES PER 10. THEY DO A LOT OF TESTING AND MENTIONED TO US IT'S A FLAW IN THE DESIGN OF THE CUP. EVEN SHORT SAMPLES ARE LEAKING AND LOSING ALL THE SAMPLES. THERE ARE SPECIAL TESTS THEY HAVE TO SEND TO ONE OF THEIR OFFSITE LAB AND THEY HAD TO USE PARAFIM TO SEAL THE LID AND STILL LEAKS AFTER IT GETS TO THE OTHER STANFORD LAB. PREVIOUS REP MENTIONED THAT THIS IS NOT THE FIRST TIME A PIR WAS SUBMITTED. THEY COMMENTED OUR CUPS ARE TOO FLIMSY AND NO MATTER HOW GOOD THEY TIGHTEN IT, IT STILL LEAKS,".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® URINE COMPLETE CUP KITS WERE LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE ARE LEAKY URINE CUPS AND THE PRODUCT IS FLIMSY. SPECIAL CIRCUMSTANCES HAVE PROMPTED STANFORD MEDICAL DIRECTOR TO HAVE ALL PRIMARY CUPS OUR BLUE CUP BE SENT TO THE LAB WITH THE TUBES. SINCE IMPLEMENTATION, THEY HAVE NOTICED THAT THERE'S A LOT OF LEAKAGE ON OUR CUPS. 4-5 SAMPLES PER 10. THEY DO A LOT OF TESTING AND MENTIONED TO US IT'S A FLAW IN THE DESIGN OF THE CUP. EVEN SHORT SAMPLES ARE LEAKING AND LOSING ALL THE SAMPLES. THERE ARE SPECIAL TESTS THEY HAVE TO SEND TO ONE OF THEIR OFFSITE LAB AND THEY HAD TO USE PARAFIM TO SEAL THE LID AND STILL LEAKS AFTER IT GETS TO THE OTHER STANFORD LAB. PREVIOUS REP MENTIONED THAT THIS IS NOT THE FIRST TIME A PIR WAS SUBMITTED. THEY COMMENTED OUR CUPS ARE TOO FLIMSY AND NO MATTER HOW GOOD THEY TIGHTEN IT, IT STILL LEAKS,"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® URINE COMPLETE CUP KITS WERE LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE ARE LEAKY URINE CUPS AND THE PRODUCT IS FLIMSY. SPECIAL CIRCUMSTANCES HAVE PROMPTED (B)(6) MEDICAL DIRECTOR TO HAVE ALL PRIMARY CUPS OUR BLUE CUP BE SENT TO THE LAB WITH THE TUBES. SINCE IMPLEMENTATION, THEY HAVE NOTICED THAT THERE'S A LOT OF LEAKAGE ON OUR CUPS. 4-5 SAMPLES PER 10. THEY DO A LOT OF TESTING AND MENTIONED TO US IT'S A FLAW IN THE DESIGN OF THE CUP. EVEN SHORT SAMPLES ARE LEAKING AND LOSING ALL THE SAMPLES. THERE ARE SPECIAL TESTS THEY HAVE TO SEND TO ONE OF THEIR OFFSITE LAB AND THEY HAD TO USE PARAFIM TO SEAL THE LID AND STILL LEAKS AFTER IT GETS TO THE OTHER (B)(6) LAB. PREVIOUS REP MENTIONED THAT THIS IS NOT THE FIRST TIME A PIR WAS SUBMITTED. THEY COMMENTED OUR CUPS ARE TOO FLIMSY AND NO MATTER HOW GOOD THEY TIGHTEN IT, IT STILL LEAKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400327 BD VACUTAINER® URINE COLLECTION CUPS SPECIMEN TRANSPORT AND STORAGE CONTAINER KDT BECTON, DICKINSON & CO. (BROKEN BOW) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other