BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 4120932 · Received July 25, 2014

    Report

    Report Number
    3002037047-2014-00088
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Report Date
    July 1, 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
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLES WERE RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOTS WERE REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO MANUFACTURER'S ACCEPTANCE CRITERIA. BECAUSE A SAMPLE WAS NOT RETURNED AND NO EVIDENCE OF NONCONFORMITY THAT COULD HAVE CAUSED THE COMPLAINT COULD BE FOUND IN THE LOT RECORD REVIEW, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT LATELY THERE WERE A LOT OF TROCAR THAT LEAK DURING SURGERY. THE HOSPITAL REPORTED THAT IT WAS ONLY ANNOYING FOR THEM SO THEY HAVE KEPT WORKING WITH LEAKING TROCARS. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436960 CUSTOM PAK CONVENIENCE KIT KYG ALCON-BELGIUM/ALCON N.V. CUSTOM PAK 392229

    Patients

    Seq Age Sex Outcome Treatment
    1 TOTALPLUS, 25+ 5.0CPM VALVE STD| CONSTELLATION LXT