BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2513663 · Received March 26, 2012

    Report

    Report Number
    2513663
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Date of Event
    February 19, 2012
    Report Date
    March 26, 2012
    Manufacturer
    COOK MEDICAL
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PIG TAIL CATHETER WAS PLACED ON THE PATIENT'S RIGHT SIDE 4TH INTERCOSTAL SPACE ALONG THE ANTERIOR AXILLARY LINE USING THE COOK MEDICAL FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET. THE NEEDLE WAS ADVANCED APPROXIMATELY ONE CM INTO THE PLEURAL CAVITY AND AIR ASPIRATION WAS CONFIRMED. THE GUIDEWIRE WAS ALSO INTRODUCED THROUGH THE NEEDLE WITHOUT DIFFICULTY AND THE NEEDLE WAS TAKEN OUT. THE MD INTRODUCED THE DILATOR THROUGH THE GUIDWIRE TO DILATE THE INSERTION SITE AND ADVANCED THE CATHETER OVER THE GUIDEWIRE. AFTER INTRODUCING THE CATHETER ABOUT ONE CM, THE MD IDENTIFIED A TEAR IN THE CATHETER OUTSIDE OF THE INSERTION SITE. THE MD ATTEMPTED TO PULL BACK THE CATHETER BUT A SMALL PORTION OF THE CATHETER BECAME DETACHED AND REMAINED IN THE PATIENT. A SURGICAL MD REMOVED A PORTION OF THE RETAINED CATHETER BUT SOME OF THE CATHETER REMAINS WITHIN THE PATIENT'S CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PIG TAIL CATHETER GBX COOK MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DAY