BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER EDTA 2K

    MDR report key: 11065976 · Received December 23, 2020

    Report

    Report Number
    1917413-2020-01247
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    November 26, 2020
    Report Date
    January 25, 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 · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-12-03. H6: INVESTIGATION SUMMARY: BD RECEIVED 2 SAMPLES AND 2 PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR EMBEDDED FM WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD VACUTAINER® EDTA 2K CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE FOLLOWING ISSUE WAS FOUND IN TUBES (367846) FROM LOT 0142783 : DIRTY CAP ×2".

    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 2 BD VACUTAINER® EDTA 2K CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE FOLLOWING ISSUE WAS FOUND IN TUBES (367846) FROM LOT 0142783 : DIRTY CAP ×2".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531471 BD VACUTAINER EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 0142783

    Patients

    Seq Age Sex Outcome Treatment
    1