BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE

    MDR report key: 7463099 · Received April 25, 2018

    Report

    Report Number
    1917413-2018-01145
    Event Type
    Malfunction
    Date Received
    April 25, 2018
    Date of Event
    December 21, 2016
    Report Date
    June 8, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JSM
    UDI-DI
    50382903649582
    PMA / PMN Number
    K024240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE TYPE IS CORRECTED TO JSM. PMA / 510(K)# IS CORRECTED TO K024240.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR MELT BACK WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR MELT BACK WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE CONTAINED MOISTURE AND THE BORIC ACID ADDITIVE WAS DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300503 BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE TRANSPORT CULTURE MEDIUM JSM BECTON, DICKINSON & CO. 6187995 50382903649582

    Patients

    Seq Age Sex Outcome Treatment
    1 Other