BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3072577 · Received April 19, 2013

    Report

    Report Number
    3002037047-2013-00028
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ALCON - BELGIUM / S.A. ALCON-COUVREUR N.V.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE ORANGE PART OF THE TROCAR DISCONNECTED FROM THE METALLIC PART WHEN THE CANNULA OR THE INSTRUMENT WAS REMOVED FROM THE TROCAR DURING A VITRECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170181 CUSTOM PAK CONVENIENCE KIT KYG ALCON - BELGIUM / S.A. ALCON-COUVREUR N.V. CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 GAUGE PRIMARY PAK 5.0 CPM