BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN CLASSIC PLUS NEEDLE HOLDER

    MDR report key: 3070235 · Received April 1, 2013

    Report

    Report Number
    3007208013-2013-00002
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    February 11, 2013
    Report Date
    April 1, 2013
    Manufacturer
    SYMMETRY SURGICAL FORMERLY CODMAN & SPECIALTY SURGICAL INSTRUMENTATION
    Product Code
    HXK
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A PERITONEAL DIALYSIS CATHETER PLACEMENT PROCEDURE, IT WAS NOTED THAT A NEEDLE HOLDER INSIDE JAW WAS MISSING. IT WAS UNK IF THE NEEDLE HOLDER WAS INTACT AT THE BEGINNING OF THE CASE. AN ABDOMINAL X-RAY WAS TAKEN AND READ AS NEGATIVE BY RADIOLOGIST AS "NO FOREIGN BODY SEEN." THERE WAS NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133144 CODMAN CLASSIC PLUS NEEDLE HOLDER HXK SYMMETRY SURGICAL FORMERLY CODMAN & SPECIALTY SURGICAL INSTRUMENTATION 36-3001 9104N

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other