BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2915077 · Received December 20, 2012

    Report

    Report Number
    1644019-2012-00230
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED AND IN-HOUSE TESTING 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A SURGEON HAD SOME DIFFICULTY WITH THE INFUSION LINE NOT STAYING IN THE PORTS. THE SURGEON TRIED USING TWO DIFFERENT TROCARS, BUT NEITHER WOULD HOLD THE LINE TIGHT. NO OTHER SURGEONS THAT OPERATE AT THE FACILITY HAVE MENTIONED SIMILAR DIFFICULTIES. ADDITIONAL INFORMATION WAS PROVIDED BY THE NURSE INDICATING THE REPORTED ISSUE WAS WITH THE NON-VALVED TROCARS. THE SURGEON NOTED THAT AT TIMES, THE INFUSION CANNULAS DO NOT "CLICK" INTO THE TROCAR. A SECOND PAK WAS USED TO COMPLETE THE CASE. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON MANUFACTURING, LTD. CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTELLATION LXT