BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH BELLY BAG 1000 ML

    MDR report key: 3950636 · Received June 5, 2014

    Report

    Report Number
    3004365956-2014-00212
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 22, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KNX
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. NO CORRECTIVE ACTION CAN BE ESTABLISHED SINCE THE DEFECTIVE SAMPLE WAS NOT RECEIVED FOR EVAL. NO CONCLUSION CAN BE ESTABLISHED AT THIS TIME BASED ON THE LACK OF DEFECTIVE OF SAMPLE. IT IS NECESSARY TO HAVE THE PHYSICAL SAMPLE IN ORDER TO PERFORM A PROPER INVESTIGATION. HOWEVER, THIS COMPLAINT WAS NOTIFIED TO THE PERSONNEL INVOLVED IN THE MANUFACTURING PROCESS, AND THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: IT WAS REPORTED THAT "WHEN THE CUSTOMER CHANGED HER BAG, SHE NOTICED THE URINE WASN'T FLOWING INTO THE BAG AS NORMAL. THE CUSTOMER CHANGED THE BAG FOR ANOTHER NEW BAG AND THE URINE FLOWED INTO THE BAG AS NORMAL." NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329673 RUSCH BELLY BAG 1000 ML BELLY BAG KNX TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1