BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4F X 55CM SINGLE PRO-PICC CT

    MDR report key: 4188447 · Received October 16, 2014

    Report

    Report Number
    2518902-2014-00067
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    August 25, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MEDCOMP
    Product Code
    JCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. THE DEVICE SAMPLE WAS FORWARDED TO THE MANUFACTURING FACILITY FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING ROUTINE PLACEMENT OF A PICC LINE, THE DILATOR SHEATH BECAME DETACHED FROM THE WINGED SET PRIOR TO BREAKING AND PEELING APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656929 4F X 55CM SINGLE PRO-PICC CT INFUSION CATHETER JCY MEDCOMP MRCTP41017 MBTR000

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention