BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHIBA BIOPSY NEEDLE

    MDR report key: 6918053 · Received October 5, 2017

    Report

    Report Number
    1820334-2017-03442
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 21, 2017
    Report Date
    January 26, 2018
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002000124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A REVIEW OF THE DEVICE HISTORY RECORD, SPECIFICATIONS, QUALITY CONTROL AND DOCUMENTATION OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. A DEVICE WAS NOT RETURNED. FIVE PHOTOS SHOWING THE FOREIGN MATTER WITHIN THE PACKAGING WERE PROVIDED BY THE CUSTOMER. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, THE ACTUAL ROOT CAUSE OF THIS FAILURE IS MANUFACTURING RELATED, AS EVIDENCED BY THE PHOTOS SENT BY THE CUSTOMER. THE QUALITY ENGINEERING RISK ASSESSMENT FOR THIS FAILURE MODE WAS REVIEWED AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. THE APPROPRIATE PERSONNEL WILL BE NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    PROCODE: MJG (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING AN PRE-USE INSPECTION OF THE CHIBA BIOPSY NEEDLE, AN UNIDENTIFIED PARTICLE WAS DISCOVERED IN THE PRIMARY PACKAGE. THE CUSTOMER CONFIRMED THAT THE DEVICE NEVER MADE CONTACT WITH ANY PATIENT; ACCORDINGLY, NO ADVERSE EVENTS OCCURRED. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698654 CHIBA BIOPSY NEEDLE KNW COOK INC N/A 00827002000124

    Patients

    Seq Age Sex Outcome Treatment
    1