BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN

    MDR report key: 7584909 · Received June 8, 2018

    Report

    Report Number
    2243072-2018-00912
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    April 19, 2017
    Report Date
    June 9, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903687744
    PMA / PMN Number
    K101502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE TYPE IS CORRECTED TO JKA. PMA / 510(K)# IS CORRECTED TO K101502.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 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 BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN HAD CLOTS/POOR BARRIER SEPARATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427084 BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 160906 50382903687744

    Patients

    Seq Age Sex Outcome Treatment
    1 Other