BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) 10.8MG PLUS BLOOD COLLECTION TUBE

    MDR report key: 9437558 · Received December 9, 2019

    Report

    Report Number
    9617032-2019-01408
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 22, 2019
    Report Date
    January 8, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, 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 HAS BEEN REPORTED THAT THE BD VACUTAINER® K2E (EDTA) 10.8MG PLUS BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING MOLDING DEFECTS AFTER USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: NBT PATHOLOGY, TRANSFUSION LAB HAS RECEIVED A SERIES OF BENT SAMPLE TUBES OVER THE LAST TWO DAYS. REASON UNKNOWN, PATIENT SAMPLES REJECTED DUE TO QUERY IS THE EDTA IN THE TUBES AFFECTED AND POSSIBLE DAMAGING INSTRUMENT PROBES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® K2E (EDTA) 10.8MG PLUS BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING MOLDING DEFECTS AFTER USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: NBT PATHOLOGY, TRANSFUSION LAB HAS RECEIVED A SERIES OF BENT SAMPLE TUBES OVER THE LAST TWO DAYS. REASON UNKNOWN, PATIENT SAMPLES REJECTED DUE TO QUERY IS THE EDTA IN THE TUBES AFFECTED AND POSSIBLE DAMAGING INSTRUMENT PROBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237010 BD VACUTAINER® K2E (EDTA) 10.8MG PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 9154919

    Patients

    Seq Age Sex Outcome Treatment
    1 Other