BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACKSON-PRATT

    MDR report key: 1891784 · Received October 22, 2010

    Report

    Report Number
    1891784
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 22, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT IS POST-OP DAY 4 FROM A C-SECTION WITH EXCESSIVE BLEEDING. J-P DRAIN(AROUND THE UTERUS) IN PATIENT. PATIENT BEGAN HAVING LOW GRADE FEVERS AND THE OBSTETRICS TEAM ATTEMPTED REMOVAL OF THE DRAIN. AT THE TIME OF THE ATTEMPTED REMOVAL OF THE DRAIN, THE TUBING SNAPPED AND THE REMAINDER OF THE DRAIN REMAINED INSIDE THE PELVIS. THE PATIENT SUBSEQUENTLY HAD A CT SCAN WHICH SHOWED THE REMAINING CONTENTS OF THE DRAIN AS WELL AS A SMALL FLUID COLLECTION AT THE BASE OF THE PELVIS. THE DRAIN WAS ULTIMATELY REMOVED FROM THE PATIENT FIVE DAYS LATER.====================== HEALTH PROFESSIONAL'S IMPRESSION======================UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACKSON-PRATT JACKSON-PRATT DRAIN GCY CARDINAL HEALTH 21500BZY00326000 1090054

    Patients

    Seq Age Sex Outcome Treatment
    1 *