BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5F X 55CM DUAL CT PICC

    MDR report key: 2840215 · Received November 14, 2012

    Report

    Report Number
    2518902-2012-00072
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 23, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MEDCOMP
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. THE DEVICE WERE FORWARDED TO THE MANUFACTURER FOR FURTHER REVIEW. WHEN THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    TEARAWAY INTRODUCER FLAPS/WINGS DETACHED FROM SHEATH. UNABLE TO RETRIEVE SHEATH PORTION FROM PT'S ARM WITHOUT SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5F X 55CM DUAL CT PICC INFUSION CATHETER-PICC LJT MEDCOMP MRCTP52017 MBLS270

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention