BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 7584237 · Received June 8, 2018

    Report

    Report Number
    9617032-2018-01873
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    April 25, 2016
    Report Date
    May 17, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K023331
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA / 510(K)#: BK050036. MEDICAL DEVICE LOT #: 5187485; MEDICAL DEVICE EXPIRATION DATE: 12/31/2016; DEVICE MANUFACTURE DATE: 07/06/2015. MEDICAL DEVICE LOT #: 5152401; MEDICAL DEVICE EXPIRATION DATE: 11/30/2016; DEVICE MANUFACTURE DATE: 06/01/2015. MEDICAL DEVICE LOT #: 5127190; MEDICAL DEVICE EXPIRATION DATE: 10/31/2016; DEVICE MANUFACTURE DATE: 05/07/2015. 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 WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD AIR BUBBLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427096 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 5236006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other