BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLASTIC MICROBIOLOGY C&S TUBE KIT WITH TRANSFER STAW/BD HEMOGARD¿

    MDR report key: 7077364 · Received December 1, 2017

    Report

    Report Number
    1917413-2017-00397
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    October 29, 2015
    Report Date
    November 7, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JSM
    UDI-DI
    00382903649594
    PMA / PMN Number
    K024240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BD RECEIVED (B)(4) SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR OPENED PACKAGING WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5061853. ROOT CAUSE MAY BE THE TEMPERATURE OF THE SEAL PLATE WAS NOT CORRECT OR IF THE TAPE THAT IS APPLIED TO THE SEAL PLATE NEEDED CHANGING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® PLASTIC MICROBIOLOGY C&S TUBE KIT WITH TRANSFER STAW/BD HEMOGARD¿ PACKAGING WAS NOT SEALED. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853343 BD VACUTAINER® PLASTIC MICROBIOLOGY C&S TUBE KIT WITH TRANSFER STAW/BD HEMOGARD¿ URINE COLLECTION SET JSM BECTON, DICKINSON & CO. 5061853 00382903649594

    Patients

    Seq Age Sex Outcome Treatment
    1 Other