BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHESOSTOMY TUBES - AIRWAY MANAGMENT

    MDR report key: 3912373 · Received May 13, 2014

    Report

    Report Number
    9611710-2014-00110
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    June 29, 2011
    Report Date
    July 6, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    JOH
    PMA / PMN Number
    K812302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVEN IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. TOW (2) LOOSE PLAIN TRACHEOSTOMY TUBES RECEIVED ON (B)(4) 2011 AND WAS TESTED ON (B)(4) 2011. RESULTS ARE AS FOLLOWS: THE PRODUCTS WERE STERILIZED. BASED ON THE WORK ORDER (B)(4) AS PRINTED ON THE PACK, THE RELATED BATCH RECORD WAS RETRIEVED FOR REVIEW. AFTER CLOSE EXAMINATION OF THE PRODUCT, IT WAS CONFIRMED THE PLAIN TRACHEOSTOMY TUBE CONTAINED INSIDE THE PACK DID NOT CORRESPOND TO THE UNIT PACK MARKINGS. IT IS CONCLUDED THAT BASED ON THE FINDINGS, COMPLAINT WAS CONFIRMED AS PER RETURNED SAMPLES AND DOCUMENTATION REVIEW. RELATED PERSONNEL WILL BE INFORMED AND APPROPRIATE CORRECTIVE ACTION WILL BE TAKEN TO PREVENT FUTURE OCCURRENCES. REPORTED TO THE FDA ON 05/12/2014. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC'S COMPLAINT HANDLING AND CAPA PROCEDURES. NOTE: THIS MDR IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BY CONVATEC FOR COMPLAINTS RECEIVED FROM 05/01/2011-09/30/2013.

    Description of Event or Problem · 1

    DETAILS OF THE COMPLAINT ARE AS FOLLOWS: " ON THE PACKAGE IT PRINTED I.D 7.0, HOWEVER, AFTER THE MEDICAL STAFF OPENED THE WRAPPER, IT PRINTED I.D 7.5 ON THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285554 TRACHESOSTOMY TUBES - AIRWAY MANAGMENT TUBE TRACHEOSTOMY AND TUBE CUFF, 73JOH JOH UNOMEDICAL SDN BHD MM62540070 539818R001

    Patients

    Seq Age Sex Outcome Treatment
    1