BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2516269 · Received March 30, 2012

    Report

    Report Number
    1644019-2012-00025
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    KNIFE EVALUATION: NO SAMPLES WERE RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. FUNCTIONAL PENETRATION AND SHARPNESS TEST VALUES FOR THE LOT MET SPECIFICATION. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A DULL KNIFE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO COMPANY ACCEPTANCE CRITERIA. THE ROOT CAUSE COULD NOT BE DETERMINED. ALL KNIVES ARE 100 PERCENT INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. PENETRATION AND SHARPNESS TESTING ARE PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. CUSTOM PAK EVALUATION: A SAMPLE HAS BEEN RECEIVED. 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 NURSE REPORTED THAT DURING A SURGICAL PROCEDURE, THE KNIFE WAS TOO DULL TO ENTER THE PATIENT'S EYE. THE KNIFE WAS EXCHANGED FOR A NEW ONE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT. IT IS ALSO NOTED THAT DURING THE SURGERY, THE DRAIN BAG WAS LEAKING. THERE WAS NO IMPACT ON THE SURGERY, AND NO HARM TO THE PATIENT, AS A RESULT OF THIS LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK 1252909H

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEARCUT SATINSLIT FULL HANDLE