BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 7484947 · Received May 3, 2018

    Report

    Report Number
    9617032-2018-00873
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    August 16, 2017
    Report Date
    June 7, 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 · 0

    MEDICAL DEVICE CATALOG # IS CORRECTED TO 367528.

    Additional Manufacturer Narrative · 0

    THIS MDR IS CORRECTED TO INCLUDE MULTIPLE PMA / 510(K) NUMBERS. THE ORIGINAL MDR INCLUDED ONLY #K023331. THIS IS CORRECTED TO INCLUDE THE INFORMATION FOR THE ADDITIONAL PMA / 510(K) NUMBER: PMA / 510(K)#: BK050036.

    Additional Manufacturer Narrative · 1

    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 FM WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR FM WAS NOT 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 THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD FM IN THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325096 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 7009757

    Patients

    Seq Age Sex Outcome Treatment
    1 Other