BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH 68 I.U. PLUS BLOOD COLLECTION TUBES

    MDR report key: 7444938 · Received April 19, 2018

    Report

    Report Number
    9617032-2018-00525
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    February 20, 2017
    Report Date
    April 17, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: ADDRESS UNAVAILABLE. BD CORPORATE ADDRESS USED. PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR (B)(6) WITH THE INCIDENT LOT WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® LH 68 I.U. PLUS BLOOD COLLECTION TUBES WERE COLLAPSED, CAUSING MACHINE PROBE TO STOP. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286240 BD VACUTAINER® LH 68 I.U. PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 6144936

    Patients

    Seq Age Sex Outcome Treatment
    1 Other