BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK GUIDE WIRE

    MDR report key: 2760198 · Received April 3, 2007

    Report

    Report Number
    2760198
    Event Type
    Injury
    Date Received
    April 3, 2007
    Date of Event
    March 13, 2007
    Report Date
    April 3, 2007
    Manufacturer
    COOK INCORPORATED
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WIRE THAT IS PLACED TO ASSIST WITH INSERTION OF CENTRAL CATHETER LINE BECAME UNRAVELED AND WHEN THE WIRE WAS PULLED OUT, A PIECE OF THE WIRE WAS LEFT IN THE PT. WIRE WAS OBTAINED AND IS BEING HELD BY THE DQM PENDING FURTHER INSTRUCTIONS FROM RISK MANAGEMENT. ANOTHER SIMILAR ISSUE WAS REPORTED TO US BY THE CONTRACTOR WHO PLACES PICCS FOR THE FACILITY. BECAUSE OF THIS ISSUE, WE ARE DISCONTINUING THE USE OF THE COOK PLIP-5 518-9 DENNY. PEEL AWAY INTRODUCER SET. WE WILL REPLACE IT WITH THE 0669050 KIT MICROINTRODUCER PTFE 10 CM 5 FR. PT REQUIRED OUTPATIENT SURVEY TO REMOVE THE BIT OF WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK GUIDE WIRE COOK GUIDE WIRE DQX COOK INCORPORATED PLIP5.5-18-9-DENNY

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other| R