BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.5F X 20CM HEMO-CATH

    MDR report key: 2722796 · Received August 22, 2012

    Report

    Report Number
    2518902-2012-00062
    Event Type
    Injury
    Date Received
    August 22, 2012
    Date of Event
    December 6, 2011
    Report Date
    August 22, 2012
    Manufacturer
    MEDCOMP
    Product Code
    DRE
    PMA / PMN Number
    06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFO REGARDING THE EVENT AND FOR THE RETURN OF THE SAMPLE FOR EVAL. WHEN THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE OF THIS REPORT: (B)(4) 2012, SUSPECT MEDICAL DEVICE: CATH SILICON 20CM DBL LUMEN, MFR NAME, CITY, STATE: MEDICAL COMPONENTS INC, (B)(4), DEVICE AVAILABLE FOR EVAL: YES. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS ADMITTED FOR ABNORMAL X-RAY AND WAS SCHEDULED FOR SURGERY FOR EXTRACTION OF FEMORAL VEIN GUIDEWIRE. ADDITIONAL INFO FROM THE USER FACILITY REPORTS: RISK MANAGEMENT RESPONDED TO CVOR PRE-OP AREA AT REQUEST OF PHYSICIAN. PT HAD BEEN ADMITTED FOR ABNORMAL X-RAY. NOW SCHEDULED FOR SURGERY FOR EXTRACTION OF FEMORAL VEIN GUIDEWIRE. PROGRESS NOTE DATED (B)(6) 2012 STATES ONLY PROCEDURE PT HAD WAS HD CATHETER INSERTION. AFTER PROCEDURE RISK MANAGEMENT THEN WENT TO CVICU WHERE THEY FOLLOWED CHAIN OF CUSTODY RETRIEVING EXTRACTED WIRE AND THEN SECURING IN THE RISK MANAGEMENT EVIDENCE CLOSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11.5F X 20CM HEMO-CATH HEMODIALYSIS CATHETER DRE MEDCOMP MCDLTSL20 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention