BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COLLECTION CUPS

    MDR report key: 8944916 · Received August 29, 2019

    Report

    Report Number
    1917413-2019-01990
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 9, 2019
    Report Date
    October 21, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    OIE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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 LABEL ERROR OCCURRED BEFORE USE WITH BD VACUTAINER® URINE COLLECTION CUPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WE USE AND DISTRIBUTE AT A HIGH VOLUME YOUR PRODUCT # 364975 WHICH IS A URINE CONTAINER WITH TRANSFER DEVICE. WE HAVE JUST RECEIVED A COMPLAINT THAT THE LABEL (CAUTION) ON THE PRODUCT WOULD ONLY BE IN ENGLISH." AS PER THEIR CONTRACT WE SHOULD PICTOGRAPH OR HAVE BILINGUAL LABELS. "

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LABEL ERROR OCCURRED BEFORE USE WITH BD VACUTAINER® URINE COLLECTION CUPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WE USE AND DISTRIBUTE AT A HIGH VOLUME YOUR PRODUCT # 364975 WHICH IS A URINE CONTAINER WITH TRANSFER DEVICE. WE HAVE JUST RECEIVED A COMPLAINT THAT THE LABEL (CAUTION) ON THE PRODUCT WOULD ONLY BE IN ENGLISH." AS PER THEIR CONTRACT WE SHOULD PICTOGRAPH OR HAVE BILINGUAL LABELS. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742025 BD VACUTAINER® URINE COLLECTION CUPS SPECIMEN TRANSPORT AND STORAGE CONTAINER OIE BECTON, DICKINSON & CO. (BROKEN BOW) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other