BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2913468 · Received January 9, 2013

    Report

    Report Number
    3002037047-2013-00003
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    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 INFO BECOMES AVAILABLE. THIS IS THE LAST OF THREE REPORTS FOR THIS FACILITY. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT BEFORE SURGERY, WHEN PRESSING THE SYRINGE, THE CANNULA CAME LOOSE FROM THE SYRINGE AND FLEW MANY FEET. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13043 CUSTOM PAK CONVENIENCE KIT KYG ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V. CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1