BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

    MDR report key: 7575717 · Received June 6, 2018

    Report

    Report Number
    1917413-2018-02005
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    March 10, 2016
    Report Date
    June 8, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JCF
    PMA / PMN Number
    K891407
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE TYPE CORRECTED TO JCF. PMA / 510(K)# CORRECTED TO K891407.

    Additional Manufacturer Narrative · 1

    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 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® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML CONTAINED FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418888 BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML BLOOD SPECIMEN COLLECTION DEVICE JCF BECTON, DICKINSON & CO. 5295540

    Patients

    Seq Age Sex Outcome Treatment
    1 Other