BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3772266 · Received December 19, 2013

    Report

    Report Number
    2028159-2013-02436
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    November 28, 2013
    Report Date
    December 2, 2013
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A TROCAR CANNULA ISSUE. IT WAS HARD TO INSERT AND REMOVED THE PROBE THROUGH THE TROCAR CANNULA DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT CONSEQUENCES TO THE PATIENT. THIS REPORT WILL ADDRESS THE TROCAR CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667688 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK 1494356H

    Patients

    Seq Age Sex Outcome Treatment
    1 25 GAUGE CUSTOM PAK