BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER GUIDING SHEATH

    MDR report key: 1901071 · Received November 10, 2010

    Report

    Report Number
    1820334-2010-00546
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED IN A USED AND NONCONFORMING CONDITION. A VISUAL EXAMINATION REVEALED THE EXTENSION TUBE HAD SEPARATED FROM THE SIDE LUMEN OF THE CHECK-FLO BODY WITHOUT EVIDENCE OF ADHESIVE RESIDUE OR MATERIAL TEAR/BREAKAGE. THIS DEVICE IS INSPECTED THROUGHOUT THE MANUFACTURING PROCESS AND AGAIN PRIOR TO SHIPMENT. ALTHOUGH MULTIPLE PROCESS CONTROLS ARE IN PLACE, IT WAS FOUND THAT NO ADHESIVE RESIDUE WAS PRESENT AT THE FAILED (SEPARATED) INTERFACE BETWEEN THE CHECK-FLO BODY AND EXTENSION TUBE. RISK ANALYSIS HAS BEEN PERFORMED RESULTING IN MEASURES BEING INITIATED TO PREVENT FUTURE COMPLAINTS OF THIS NATURE. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE ARE CONTINUING TO MONITOR COMPLAINTS FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    SEPARATION OF THE LATERAL WAY WHEN THE INTRODUCER WAS IN PATIENT; RESULTING IN A HEMORRHAGE. NO DEATH OCCURRED. NO INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME/CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMER GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA F2465267

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK