BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OR/GASTRO/STOMACH

    MDR report key: 3912404 · Received May 13, 2014

    Report

    Report Number
    3005778470-2014-00021
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS FURTHER REPORTED THAT THE PRODUCT WAS NOT USED ON THE PT. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON 05/12/2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CONNECTION BETWEEN CATHETER TUBE AND THE HUB IS LEAKY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285652 OR/GASTRO/STOMACH TUBE, FEEDING, 78FPD FPD UNOMEDICAL S.R.O. 23038339 498163

    Patients

    Seq Age Sex Outcome Treatment
    1