BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 4253245 · Received November 13, 2014

    Report

    Report Number
    1644019-2014-00191
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS THE FIRST COMPLAINT REPORTED FOR THIS ISSUE. THIS IS THE FIRST COMPLAINT REPORTED FOR THIS CUSTOM PAK LOT. REVIEW OF THE DHR (DEVICE HISTORY RECORD) INDICATES THE ORDER WAS BUILT TO SPECIFICATION. SAMPLE HAS NOT BEEN RETURNED. FILE WILL BE PROCESSED FOR CLOSURE AND OPENED AT A LATER DATE IF THE SAMPLE IS RECEIVED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NOT KNOWN; A SAMPLE WAS NOT RETURNED FOR INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECHNICIAN REPORTED THAT A NEEDLE WOULD NOT STAY LOCKED ONTO A SYRINGE DURING A PROCEDURE. THE SURGEON HELD THE NEEDLE WHILE INJECTING FLUID AND FELT THE NEEDLE RELEASE WHEN PUSHING FLUID THROUGH IT. THERE WAS NO HARM TO THE PATIENT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733212 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK 1638571H

    Patients

    Seq Age Sex Outcome Treatment
    1