BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX TLS

    MDR report key: 3151615 · Received April 16, 2013

    Report

    Report Number
    3151615
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 16, 2013
    Manufacturer
    SMITHS MEDICAL
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    JACKSON-PRATT (JP) DRAIN ORDERED TO BE REMOVED. SUCTION TO BULB REMOVED. SUTURE CUT AT SKIN. TUBING PULLED AT INSERTION SITE. WHEN PULLED, TUBING OF DRAIN BROKE. PHYSICIAN WAS NOTIFIED. THE PATIENT RETURNED TO SURGERY FOR REMOVAL OF JP DRAIN FROM NECK.ORIGINAL SURGERY WHEN JP WAS PLACED WAS A RIGHT CAROTID ENDARTERECTOMY ONE DAY PRIOR.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ORIGINAL SURGERY WHEN JP WAS PLACED WAS A RIGHT CAROTID ENDARTERECTOMY ONE DAY PRIOR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163282 PORTEX TLS APPARATUS, SUCTION GCY SMITHS MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR