BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEOSTOMY TUBES - AIRWAY MANAGEMENT

    MDR report key: 3874215 · Received April 23, 2014

    Report

    Report Number
    9611710-2014-00066
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 25, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    JOH
    PMA / PMN Number
    K945874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS FURTHER REPORTED THAT THE MEDICAL STAFF REMOVED THE DEVICE AFTER THEY FOUND THE DEFECT AND REPLACED IT WITH A NEW ONE. A QUALITY EVALUATION WAS PERFORMED ON (B)(4) 2014. THE PRODUCT WAS TESTED ON (B)(4) 2014. RECEIVED WAS ONE USED I.D 7.5MM, TRACHEOSTOMY TT BASIC TUBE WITH FROSTY BALLOON. PRODUCT FITTED WITH PVC BULLET VALVE, CONNECTOR AND NECKSTRAP OF CORRESPONDING SIZE. PILOT BALLOON PRINTED WITH SIZE IDENTIFICATION AND WORK ORDER # (B)(4). UNDER CLOSE EXAMINATION IT WAS OBSERVED THAT THE SWIVEL CONNECTOR WAS DROPPED OFF FROM THE NECKSTRAP ASSEMBLY. THE WHITE OD AND ID OF THE MACHINE END OF SWIVEL CONNECTOR AND OD OF CONNECTOR FIXATION WERE ALL MEASURED AND WERE FOUND TO BE WITHIN SPECIFICATION. REVIEW OF THE INCOMING INSPECTION REPORT FOR THE NECKSTRAP USED IN THE WORK ORDER DID NOT REVEAL ANY SIGNS OF DIMENSIONAL FAILURE. THE DIMENSION OF THE NECKSTRAP WAS FOUND TO BE WELL WITHIN THE SPECIFICATION WHEN MEASURED DURING INCOMING INSPECTION UPON RECEIPT OF THE RAW MATERIAL. REVIEW OF THE ASSEMBLY WORK ORDER DID NOT REVEAL ANY SIGN OF ASSOCIATED DEFECT DETECTED DURING ASSEMBLY OR INSPECTION. AN ANALYSIS ON THE RETURNED SAMPLE SHOWED THAT IT MET SPECIFICATION. IN ADDITION, THE FUNCTION OF THE TRACHEOSTOMY TUBE IS NORMAL DURING USE BUT THE CONNECTOR DETACHED WITHIN ONE WEEK DURING USAGE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    COMPLAINANT REPORTS THE 15MM WHITE SWIVEL CONNECTOR DETACHED WITHIN ONE WEEK DURING USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245164 TRACHEOSTOMY TUBES - AIRWAY MANAGEMENT TUBE TRACHEOSTOMY AND TUBE CUFF JOH UNOMEDICAL SDN BHD MM62525075 543225R001

    Patients

    Seq Age Sex Outcome Treatment
    1