BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3912854 · Received May 14, 2014

    Report

    Report Number
    3002037047-2014-00055
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ALCON - BELGIUM/ ALCON N.V.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED FOR IN HOUSE TESTING. 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. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. ANY DEFECTS, SUCH AS DAMAGED TIPS AND CUTTING EDGES, ARE REMOVED FROM THE LOT AND SCRAPPED. SHARPNESS TESTING IS PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A DULL KNIFE WAS DISCOVERED BEFORE CONTACT WITH THE PATIENT. THE KNIFE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288486 CUSTOM PAK CONVENIENCE KIT KYG ALCON - BELGIUM/ ALCON N.V. CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEARCUT 2.2 MILLIMETER KNIFE