BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER EDTA 2K

    MDR report key: 11179436 · Received January 15, 2021

    Report

    Report Number
    1917413-2021-00026
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 16, 2020
    Report Date
    February 7, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 2021-01-05. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND 5 PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR EMBEDDED FM IN SHIELD, FM, AND FM-INK WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, ALL CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR EMBEDDED FM IN SHIELD, FM, AND FM-INK 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 16 BD VACUTAINER® EDTA 2K CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE FOLLOWING ISSUES WERE FOUND IN TUBES (367846) FROM LOT: 0142783: DIRTY CAP ×14, FM IN TUBE ×1, DIRTY TUBE ×1".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 16 BD VACUTAINER® EDTA 2K CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE FOLLOWING ISSUES WERE FOUND IN TUBES (367846) FROM LOT 0142783: DIRTY CAP ×14, FM IN TUBE ×1, DIRTY TUBE ×1".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75204 BD VACUTAINER EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 0142783

    Patients

    Seq Age Sex Outcome Treatment
    1