BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBE

    MDR report key: 10233435 · Received July 6, 2020

    Report

    Report Number
    1917413-2020-00555
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 15, 2020
    Report Date
    July 9, 2020
    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

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT ONE PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTOS WERE REVIEWED 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 THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBE EXPERIENCED FOREIGN MATTER IN THE TUBE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIGHT BROWN-COLORED FM WAS FOUND IN A TUBE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE LOT #: AN INVALID LOT # OF 9260456 WAS PROVIDED. THE CORRECT LOT # IS NOT KNOWN AT THIS TIME. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBE EXPERIENCED FOREIGN MATTER IN THE TUBE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIGHT BROWN-COLORED FM WAS FOUND IN A TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695662 BD VACUTAINER K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other