BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3181967 · Received June 17, 2013

    Report

    Report Number
    3002037047-2013-00061
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 21, 2013
    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
    FR
    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE INFUSION LINE DID NOT CLIP ONTO THE TROCAR DURING A PROCEDURE. THERE WAS NO HARM TO THE PT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272830 CUSTOM PAK CONVENIENCE KIT KYG ALCON - BELGIUM/ ALCON N.V. CUSTOM PAK 353471

    Patients

    Seq Age Sex Outcome Treatment
    1 PRIMARY PAK 23 5.0 CPM