BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEOBRONCHIAL (OPEN) SUCTIONING-AIRWAY MGMT

    MDR report key: 3963088 · Received June 20, 2014

    Report

    Report Number
    3005778470-2014-00036
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    BSY
    PMA / PMN Number
    K896730
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. ADDITIONAL INFORMATION WAS RECEIVED BY EMAIL ON (B)(6) 2014 INFORMING WHEN THE CUSTOMER USED THE DEVICE ON THE PATIENT WITH TRACHEOTOMY; THE CONNECTOR BROKE OFF COMING AWAY FROM THE TUBING. THEY WENT ON TO STATE "TUBE SEPARATE FROM THE CONNECTOR AND NEARLY GOT IN TO THE PATIENT'S ESOPHAGUS, BUT THEY MANAGE TO STOP THE TUBE." A QUALITY EVALUATION WAS PERFORMED ON (B)(6) 2014. NO SAMPLES HAVE BEEN AVAILABLE FOR INVESTIGATION. INVESTIGATION PROCESS HAS BEEN PERFORMED BASED ON THE HISTORICAL DATA OF MANUFACTURING PROCESS. DEVICE HISTORY RECORDS WERE CHECKED. THE RESULTS OF REVIEW SHOWED THAT AL RELEVANT TESTS PERFORMED DURING MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE WERE FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY WAS REGISTERED DURING MANUFACTURING AS WELL AS THE PACKAGING PROCESS. NO OTHER COMPLAINT OF THIS NATURE HAS BEEN RECEIVED ON THE BATCH. NO INCREASING TREND ON COMPLAINT AMOUNT REGARDING PRODUCT REFERENCE CODE AND FAILURE IN QUESTION HAS BEEN REGISTERED WITHIN LAST 24 MONTHS. BASED ON THE INFORMATION RECEIVED AND INVESTIGATION FINDINGS WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THE FAILURE. THE FAILURE IS INCLUDED IN RELEVANT RISK MANAGEMENT FILE AND ASSOCIATED HAZARD IS EVALUATED THERE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    IT WAS REPORTED " THE CONNECTOR OF THE SUCTION-TUBE, DISCONNECTED WHEN THEY USED IT!"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362619 TRACHEOBRONCHIAL (OPEN) SUCTIONING-AIRWAY MGMT CATHETERS, SUCTION, TRACHEOBRONCHIAL 73BSY BSY UNOMEDICAL S.R.O. 05084181 486889

    Patients

    Seq Age Sex Outcome Treatment
    1