BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7623292 · Received June 20, 2018

    Report

    Report Number
    9617032-2018-02437
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    December 13, 2016
    Report Date
    June 20, 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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR OTHER LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6243575, MEDICAL DEVICE EXPIRATION DATE: 12/31/2017, DEVICE MANUFACTURE DATE: 08/30/2016. BD RECEIVED PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THIS COMPLAINT IS CONFIRMED TO BE WITHIN THE SCOPE OF A KNOWN ISSUE. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. NO FURTHER ACTION IS REQUIRED AT THIS TIME. BASED ON EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT MEETS THE CRITERIA FOR A PREVIOUSLY INVESTIGATED COMPLAINT; REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES WERE COLLAPSED. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466100 BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 6243576 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other