BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2932476 · Received January 24, 2013

    Report

    Report Number
    1644019-2013-00010
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 26, 2012
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 SURGEON REPORTED THAT DURING A PROCEDURE, THE INFUSION CANNULA TIP WAS OBSERVED TO BE DEFORMED. AN ALTERNATE INFUSION CANNULA WAS USED, AND THE CASE WAS COMPLETED WITHOUT HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34902 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK 1359088H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 25G TOTAL PLUS PAK VALVED| CONSTELLATION VISION SYSTEM