BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JACKSON PRATT

    MDR report key: 5145185 · Received September 10, 2015

    Report

    Report Number
    5145185
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    August 29, 2015
    Report Date
    September 9, 2015
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON REMOVED JACKSON PRATT AT BEDSIDE. THE JACKSON PRATT BROKE. THE JACKSON PRATT WAS UNABLE TO BE REMOVED IN ITS ENTIRETY AT THE BEDSIDE. THE END OF THE JACKSON PRATT WAS RETAINED. THE PHYSICIAN PERFORMED A DIAGNOSTIC LAPAROSCOPY AND JACKSON PRATT REMOVAL. THE END OF THE JACKSON PRATT DRAIN WAS FOUND TO BE IN PLACE AND WAS REMOVED COMPLETELY. THE FACILITY HAD TWO LOTS IN CIRCULATION. WE NARROWED THE BROKEN DEVICE DOWN TO ONE FO THESE TWO LOT NUMBERS 1150304 OR 1150306. DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE RETAINED PIECE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601199 JACKSON PRATT JP DRAIN GCD CARDINAL HEALTH REF SU13-1309

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R