BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER EDTA 2K

    MDR report key: 10826416 · Received November 11, 2020

    Report

    Report Number
    1917413-2020-01138
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    October 14, 2020
    Report Date
    December 2, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED SAMPLES AND 3 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR EMBEDDED FM WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR EMBEDDED FM WITH THE INCIDENT LOT WAS OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® EDTA 2K HAD FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE FOLLOWING ISSUES WERE FOUND IN TUBES (367846) FROM LOT 0100257: SPOT IN TUBE X2 DIRTY TUBE X1

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® EDTA 2K HAD FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE FOLLOWING ISSUES WERE FOUND IN TUBES (367846) FROM LOT 0100257: SPOT IN TUBE X2, DIRTY TUBE X1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287355 BD VACUTAINER EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 0100257

    Patients

    Seq Age Sex Outcome Treatment
    1