BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERJECT¿

    MDR report key: 5937940 · Received September 8, 2016

    Report

    Report Number
    3005099803-2016-02745
    Event Type
    Malfunction
    Date Received
    September 8, 2016
    Date of Event
    August 12, 2016
    Report Date
    August 12, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FCG
    PMA / PMN Number
    K012864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MDR WILL BE FILED. BOSTON SCIENTIFIC CORPORATION IS IN THE PROCESS OF INVESTIGATING THIS EVENT TO UNDERSTAND THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE STERILE PACKAGING OF THE INTERJECT NEEDLE WAS PERFORATED. REPORTEDLY, THE ISSUE WAS FOUND AT THE DISTRIBUTOR PRIOR TO DELIVERY TO THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE STERILE PACKAGING OF THE INTERJECT NEEDLE WAS PERFORATED. REPORTEDLY, THE ISSUE WAS FOUND AT THE DISTRIBUTOR PRIOR TO DELIVERY TO THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587520 INTERJECT¿ BIOPSY NEEDLE KIT FCG BOSTON SCIENTIFIC - SPENCER M00518151 19319825

    Patients

    Seq Age Sex Outcome Treatment
    1