BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER EDTA 2K

    MDR report key: 11372701 · Received February 24, 2021

    Report

    Report Number
    1917413-2021-00125
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    January 29, 2021
    Report Date
    February 3, 2021
    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 · 1

    (B)(4). INVESTIGATION SUMMARY: BD RECEIVED 3 SAMPLES AND 3 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FM AND EMBEDDED FM WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR FM AND 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 · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® EDTA 2K TUBES THERE WAS FOREIGN MATTER IN THE TUBES BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: THE FOLLOWING ISSUE WAS FOUND IN TUBES (B)(4) FROM LOT 0191214: DIRTY TUBE ×3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271912 BD VACUTAINER EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 0191214

    Patients

    Seq Age Sex Outcome Treatment
    1