BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCT CTH KIT W/O SOL SFTY-VAC 10FR

    MDR report key: 5494635 · Received March 11, 2016

    Report

    Report Number
    9612030-2016-00106
    Event Type
    Malfunction
    Date Received
    March 11, 2016
    Report Date
    July 25, 2013
    Manufacturer
    KENMEX
    Product Code
    OFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE A LOT NUMBER WAS NOT PROVIDED. MANUFACTURING RECORDS ARE ROUTINELY REVIEWED PRIOR TO THE RELEASE OF PRODUCT TO ENSURE PROCESS AND PRODUCT ARE ACCORDING THE SPECIFICATIONS; NO FINDINGS RELATED TO THE REPORTED CONDITION WERE REPORTED. THERE WERE NO SAMPLES RETURNED FOR THIS COMPLAINT. THE COMPLAINT SHALL BE REOPENED IF A SAMPLE IS RECEIVED. BECAUSE THE SAMPLE HAS NOT BEEN RECEIVED THE FAILURE MODE COULD NOT BE CONFIRMED; THEREFORE, THE ROOT CAUSE WAS NOT IDENTIFIED. AS PART OF THE INJECTION MOLDING PROCESS THE MELTED RESIN FLOWS FROM THE MACHINE BARREL THROUGH THE MOLD MANIFOLD AND AFTER THAT FILLING THE MOLD CAVITIES. DURING THE NATURAL FLOW OF THE RESIN, VENT LINES ARE PART OF THE MOLD DESIGN TO FACILITATE THE AIR FLOW THROUGH THE INJECTION MOLDING PROCESS. SOME VENT LINES COULD BE BLOCKED OR INACCESSIBLE AND THAT COULD GENERATE THE ENTRAPMENT OF AIR CAUSING THE REPORTED CONDITION. A PRODUCTION NOTIFICATION WAS SENT OUT TO ALL PERSONNEL TO ENSURE THAT THEY ARE AWARE ON THE CONDITION REPORTED BY THE CUSTOMER AND THE INSPECTION PLAN FOR THE VALVES WAS MOVED TO TIGHT. IF ADDITIONAL INFORMATION IS RECEIVED WARRANTING FURTHER ANALYSIS, THE INVESTIGATION WILL BE RESUMED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A GAUZE SPONGE. THE CUSTOMER REPORTS: SUCTION CATHETERS USED FOR SUCTIONING MUCUS WHEN A TRACH IS ALREADY IN PLACE. THE SUCTION CATHETERS ARE OCCLUDED AND NOT SUCTIONING CORRECTLY. NO AIR FLOW IS GOING THROUGH TO PRODUCE SUCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152694 SUCT CTH KIT W/O SOL SFTY-VAC 10FR SUCTION CATHETER OFR KENMEX 37024 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1