BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLASTIC MICROBIOLOGY C&S TUBES KIT, TRANSFER STRAW/BD HEMOGARD¿

    MDR report key: 7066643 · Received November 29, 2017

    Report

    Report Number
    1917413-2017-00344
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    September 30, 2015
    Report Date
    January 22, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JSM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE VISUALLY INSPECTED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR IMPROPER SEAL WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT #5061853 AND NO ISSUES WERE IDENTIFIED. THE PROBABLE ROOT CAUSE IS A MANUFACTURING DEFICIENCY.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH A 510K NUMBER BUT THIS DEVICE IS PRE-AMENDMENT AND DOES NOT HAVE A 510K ASSOCIATED WITH IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SEAL OF BD VACUTAINER® PLASTIC MICROBIOLOGY C&S TUBES KIT, TRANSFER STRAW/BD HEMOGARD¿ BORIC ACID, SODIUM FORMATE AND SODIUM BORATE PRESERVATIVE 4ML 13X75MM WAS NOT SEALED PROPERLY SO NOT STERILE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848894 BD VACUTAINER® PLASTIC MICROBIOLOGY C&S TUBES KIT, TRANSFER STRAW/BD HEMOGARD¿ URINE COLLECTION TUBE JSM BECTON, DICKINSON & CO. 5061853

    Patients

    Seq Age Sex Outcome Treatment
    1 Other