BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7468773 · Received April 27, 2018

    Report

    Report Number
    1917413-2018-01056
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    October 12, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR AIR BUBBLES IN THE GEL WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR AIR BUBBLES IN THE GEL 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® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML HAD AIR BUBBLES IN THE GEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313691 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