BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JACKSON-PRATT

    MDR report key: 3171926 · Received December 4, 2006

    Report

    Report Number
    3171926
    Event Type
    Injury
    Date Received
    December 4, 2006
    Date of Event
    October 25, 2006
    Report Date
    October 27, 2006
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    GCY
    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

    WHILE TRYING TO REMOVE A JACKSON-PRATT DRAIN FROM POSTOPERATIVE PATIENT PRIOR TO DISCHARGE, THE TUBING BROKE OR FRACTURED OFF LEAVING A PORTION OF THE DRAIN IN THE PATIENT'S ABDOMEN. PATIENT WAS RETURNED TO THE OPERATING ROOM FOR REMOVAL OF FOREIGN BODY UNDER GENERAL ANESTHESIA. DRAIN WAS INSPECTED AFTER REMOVAL. NO SUTURES HAD BEEN PLACED ON PORTION OF THE DRAIN THAT HAD BEEN IN THE ABDOMEN. PATIENT'S LOS INCREASED BY ONE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACKSON-PRATT JP DRAIN-RESERVOIR KIT W/SILICONE FLAT GCY CARDINAL HEALTH, INC. 10MM 1060732

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R