BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION CATHETERS

    MDR report key: 3870129 · Received April 29, 2014

    Report

    Report Number
    3005778470-2014-00015
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 31, 2014
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. FURTHER INFO PROVIDED VIA EMAIL ON (B)(6) 2014 INFORMING THAT THE DEVICE WITH THE FLY INSIDE WAS RETURNED TO THE COMPANY. THE PRODUCT WAS NOT USED. THEY INFORMED THAT THE PRODUCT WAS IN A SEALED PACKAGE THAT WAS NOT DAMAGED AND THERE WAS NO APPEARANCE OF IT BEING COMPROMISED. IT WAS FURTHER REPORTED THAT THE PRODUCT WAS STORED TO THE NORMAL HOSPITAL WARN ENVIRONMENT AND WAS TO BE USED FOR ENDOTRACHEAL SUCTIONING. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE BUT, TO DATE NO SAMPLE HAS BEEN REC'D. WHEN THE SAMPLE IS REC'D, AN INVESTIGATION WILL BE PERFORMED. IT IS DOCUMENTED THAT THE COMPLAINT ISSUE WAS REPORTED TO THE (B)(6). NO ADD'L PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE A F/U REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON APRIL 29, 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "FLY WITHIN THE SUCTION CATHETER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256674 SUCTION CATHETERS CATHETERS, SUCTION, TRACHEOBRONCHIAL BSY UNOMEDICAL S.R.O. 115.06.058 470381

    Patients

    Seq Age Sex Outcome Treatment
    1