BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3915546 · Received June 4, 2014

    Report

    Report Number
    1644019-2014-00100
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 7, 2014
    Manufacturer
    AALCON - HOUSTON
    Product Code
    KYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVAL; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A LOT NUMBER WAS NOT INDICATED FOR THIS COMPLAINT; THEREFORE, THE DEVICE HISTORY RECORD (DHR) FOR THE LOT COULD NOT BE REVIEWED FOR ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER WAS INDICATED FOR THIS COMPLAINT, THE ROOT CAUSE CANNOT BE DETERMINED. NO FURTHER INFO IS EXPECTED FOR THIS CASE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT LEAKAGE OCCURRED FROM THE VALVED TROCAR CANNULA WHEN IT WAS PLACED IN THE PT'S EYE AND THE TROCAR WAS REMOVED. THE PROBLEM WAS SOLVED AFTER REPLACING WITH ANOTHER ONE. THERE WAS NO HARM TO THE PT. NO FURTHER INFO IS EXPECTED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326059 CUSTOM PAK CONVENIENCE KIT KYG AALCON - HOUSTON CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 VALVED, 0.9 J CONSTELLATION VISION SYSTEM LXT| COMINDED PROCEDURE PACK, 23G 5000 CUTS PER MINUTE,