BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOMPAK

    MDR report key: 3915548 · Received June 4, 2014

    Report

    Report Number
    1644019-2014-00102
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION. 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. NO FURTHER INFORMATION IS EXPECTED FOR THIS CASE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A TROCAR LEAKED DURING A SURGERY. NO HARM TO THE PATIENT WAS REPORTED. THE SURGERY WAS COMPLETED. NO FURTHER INFORMATION IS EXPECTED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325648 CUSTOMPAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 TOTAL PLUS, 25+ 5.0CPM VALVE STD