BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN

    MDR report key: 1770381 · Received July 21, 2010

    Report

    Report Number
    MW5016805
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 16, 2010
    Manufacturer
    CODMAN & SHURTLEFF (J&J)
    Product Code
    CAZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE FRICTION CONNECTOR BETWEEN THE CS CATHETER AND THE EPIDURAL PUMP TUBING CAME OUT OF THE ADHESIVE SECUREMENT DEVICE. WHEN THE PT SAT UP IN THE BED, THE IV TUBING PULLED OUT FROM THE FRICTION CONNECTOR. AS A RESULT, CSF FLUID WAS LOST FROM THE PT AND TUBING CONTAMINATED. CATHETER WAS REMOVED. THIS HAS HAPPENED BEFORE WITH THIS CATHETER/TUBING TYPE. PT COMPLAINT OF HEADACHE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN EPIDURAL CATHETERIZATION KIT WITH FLEX TIP PLUS CATHETER CAZ CODMAN & SHURTLEFF (J&J) AP-08100, 19GA RF9027653

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization