BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAIN JACKSONPRATT FL7MM3/4 PE

    MDR report key: 1617146 · Received February 5, 2010

    Report

    Report Number
    1423507-2010-00005
    Event Type
    Other
    Date Received
    February 5, 2010
    Date of Event
    October 29, 2009
    Report Date
    February 3, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO HAS BEEN FORWARDED TO THE SUPPLIER. RESULTS OF INVESTIGATION PENDING. A FOLLOW-UP MEDWATCH REPORT WILL BE FILED. THE REPORTER DOES WANT THEIR IDENTITY DISCLOSED. ADDITIONAL INFO FROM VOLUNTARY REPORT: (B)(6).

    Description of Event or Problem · 1

    PER MEDWATCH FORM RECEIVED, "SURGEON ATTEMPTED TO REMOVE JACKSON PRATT CATHETER FROM THE MID BACK ON A PT WHO WAS 3 DAYS POST OPERATIVE FOR LUMBAR LAMINECTOMY. THE SURGEON STATES THERE WAS A FAILURE BETWEEN THE INTERCONNECTION OUTFLOW AND THE DRAIN PORTION LEADING TO INABILITY TO DISCONTINUE LEADING TO A PORTION OF RETAINED TUBING. AN ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED IN ATTEMPTS TO REMOVE THE RETAINED JP TUBING. INITIALLY, ULTRASOUND AND A HEMOSTAT WERE USED TO FIND AND REMOVE THE DRAIN. AFTER THREE ATTEMPTS, DECISION WAS MADE TO MAKE A SMALL INCISION (APPROX 1/2 INCH). THE DRAIN WAS VISUALIZED AND REMOVED WITHOUT SEQUELAE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAIN JACKSONPRATT FL7MM3/4 PE WOUND DRAIN GCY CARDINAL HEALTH SU130-1308 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention