BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TT BASIC HVLP 7.0MM

    MDR report key: 5048574 · Received September 1, 2015

    Report

    Report Number
    9611710-2015-00154
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Report Date
    August 4, 2015
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2015. MFR DATE: 05/2014. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY. ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN REQUESTED. HOWEVER, NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. A QUALITY COMPLAINT INVESTIGATION WAS PERFORMED. A USED TRACHEOSTOMY TUBE FITTED WITH A PVC BULLET VALVE, CONNECTOR, AND NECKSTRAP ASSEMBLY OF CORRESPONDING SIZE WAS RECEIVED FOR EVALUATION. THE PRODUCT WAS EXAMINED CLOSELY AND NO VISUAL DEFECTS COULD BE OBSERVED. THE BALLOON COULD BE EASILY INFLATED WITH AIR VIA A LUER TIP SYRINGE INSERTED INTO THE BULLET VALVE AND KEPT ASIDE FOR 24 HOURS TO CHECK FOR LEAKAGE. NO LEAKAGE COULD BE OBSERVED. DEFLATION WAS EASY AND NORMAL. THE BALLOON WAS RE-INFLATED WITH AIR AND THE ENTIRE TUBE WAS SUBMERGED INTO A BEAKER OF WATER. NO LEAKAGE COULD BE OBSERVED EITHER ON THE TUBE, PILOT BALLOON, PILOT ASSEMBLY, OR NECKSTRAP ASSEMBLY AND BALLOON AS NO AIR BUBBLES COULD BE SEEN. THE ENTIRE TUBE WAS SUBMERGED INTO A BEAKER OF WATER, AIR WAS INTRODUCED VIA THE MACHINE END OF THE CONNECTOR WITH A BIG SYRINGE AND THE OPEN END OF THE TIP WAS CLOSED. AIR BUBBLES COULD BE SEEN ESCAPING AWAY FROM THE SURROUNDING OF THE MAIN TUBE JOINT INDICATING THAT THERE IS POTENTIAL OF LEAKAGE AT THIS AREA. COLORED WATER WAS INTRODUCED TO THE TUBE VIA THE MACHINE END OF THE CONNECTOR AND IT DRAINED OUT OF THE AREA. CLOSE EXAMINATION OF THE TUBE UNDER MAGNIFICATION REVEALED THAT THERE IS A SMALL GAP AT THE MAIN TUBE JOINT AREA. THIS DEFECT MOST LIKELY DUE TO IMPROPER INSERTING/JOINING THE TUBE END DEPTH TO THE NECKSTRAP ASSEMBLED DURING GLUING OF NECKSTRAP ASSEMBLY TO MAIN TUBE PROCESS CAUSING A VOID IN BETWEEN THE TUBE AND NECKSTRAP ASSEMBLED. REVIEWING OF THE ASSEMBLY WORK ORDER REVEAL 1.7% OF LUMEN TEST DEFECT DURING THE 100% INSPECTION AND THE DEFECTIVE PART WAS REJECTED AND DISCARDED. THE ANALYSIS ON THE RETURNED SAMPLE PROVIDED WAS TESTED AND DID NOT PERFORM TO OUR SPECIFICATIONS. RELATED PERSONNEL WILL BE INFORMED AND AN INTERNAL NONCONFORMANCE WILL BE CREATED TO ADDRESS THIS CONFIRMED ISSUE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON SEPTEMBER 01, 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED AND RECEIVED VIA PHOTO ON (B)(6) 2015, THAT "AIR LEAKAGE WAS NOTED AROUND THE CONNECTOR JUST A WHILE AFTER USE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577826 TT BASIC HVLP 7.0MM TUBE, TRACHEAL(W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD MM62525070

    Patients

    Seq Age Sex Outcome Treatment
    1