BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2913546 · Received December 21, 2012

    Report

    Report Number
    1644019-2012-00228
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RECEIVED AND IN-HOUSE EVAL IS IN PROGRESS. 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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING A PROCEDURE, THE INFUSION LINE WOULD NOT STAY IN THE NON-VALVED TROCAR. THE CASE WAS COMPLETED USING AN ALTERNATE INFUSION LINE AND VALVED TROCAR. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK 1345165H

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTELLATION VISION SYSTEM| 23GA PRIMARY PAK