BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 7477537 · Received May 1, 2018

    Report

    Report Number
    9617032-2018-00707
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    March 30, 2017
    Report Date
    April 23, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903688611
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. (B)(6). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7018944, MEDICAL DEVICE EXPIRATION DATE: 2018-05-31, DEVICE MANUFACTURE DATE: 2017-01-18. MEDICAL DEVICE LOT #: 6350996, MEDICAL DEVICE EXPIRATION DATE: 2018-04-30, DEVICE MANUFACTURE DATE: 2016-12-15. MEDICAL DEVICE LOT #: 7010777, MEDICAL DEVICE EXPIRATION DATE: 2018-04-30, DEVICE MANUFACTURE DATE: 2017-01-10. MEDICAL DEVICE LOT #: 7010778, MEDICAL DEVICE EXPIRATION DATE: 2018-05-31, DEVICE MANUFACTURE DATE: 2017-01-10, 7010778, CREATION DATE: 2017-01-10, EXP DATE: 2018-05-31.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES WERE EXPERIENCING CORING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318275 BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 7018944 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other