BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, DRAINAGE, FUHRMAN PLEURAL, PNEUMOPERICARDIAL

    MDR report key: 2464335 · Received February 8, 2012

    Report

    Report Number
    2464335
    Event Type
    Injury
    Date Received
    February 8, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 8, 2012
    Manufacturer
    COOK MEDICAL
    Product Code
    EYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CHEST TUBE WAS IRRIGATED WITH 10 CC OF NORMAL SALINE BY THE ATTENDING PHYSICIAN IN THE AFTERNOON DUE TO NO DRAINAGE NOTED. THERE WAS NO DIFFICULTY IRRIGATING THE CATHETER. FOUR HOURS LATER, THE RN NOTED THAT THE PATIENT'S RIGHT CHEST TUBE SITE WAS SATURATED. THE DRESSING WAS TAKEN DOWN AND THE PIGTAIL CATHETER WAS NOTED TO BE BROKEN AT THE HUB OF THE CATHETER. THE REMAINDER OF THE CATHETER HAD TO BE SURGICALLY REMOVED AT THE BEDSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, DRAINAGE, FUHRMAN PLEURAL, PNEUMOPERICARDIAL 8.5 FR 15 CM PIGTAIL CATHETER EYB COOK MEDICAL C-PPD-850-IMH G55723

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other| R