BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT

    MDR report key: 3876896 · Received May 20, 2014

    Report

    Report Number
    9611710-2014-00121
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    June 5, 2011
    Report Date
    July 18, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K96238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE INFO. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ONE (1) UNUSED SAMPLES RECEIVED ON (B)(4) 2011 AND TESTED ON (B)(4) 2011. RESULTS FROM THE INVESTIGATION ARE AS FOLLOWS: PRODUCT WAS CLOSELY EXAMINED AND WAS CONFIRMED THAT THERE IS A MISPRINT ON THE TUBE WAS PRINTED WITH I.D. 7.0MM IN "UNOMEDICAL" LABEL FOUND NOT CORRESPONDING AS PRINTED ON THE (B)(4) PREPRINTED PACK. HOWEVER, LOT #608052R001 AND SIZE 7.0MM ON THE PILOT BALLOON FOUND CORRESPONDING TO THE VARIABLE INFO AS PRINTED ON THE UNIT PACK. SUCH DEFECT COULD HAVE PROBABLY BEEN DUE TO "INCORRECT PRINTING CLICHE BLOCK" THAT HAD BEEN USED TO RE-PRINT THE TUBE THAT INVOLVED THE REWORK PRINTING. ACCURACY OF THE RE-PRINT WAS NOT VERIFIED PROPERLY WHICH LEADS TO DEFECT FOUND BY THE CUSTOMER. IT IS CONCLUDED THAT THE COMPLAINT WAS CONFIRMED AS PER RETURNED SAMPLES. AN INTERNAL CORRECTIVE ACTION EVENT HAS BEEN TAKEN FOR A SIMILAR COMPLAINT, AND THIS PARTICULAR LOT (608052R001) IDENTIFIED WAS CONFIRMED TO BE MANUFACTURED BEFORE IMPLEMENTATION OF THE CAPA. NOTE: THIS MDR IS REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BY (B)(4) FOR COMPLAINTS RECEIVED FROM (B)(4) 2011 - (B)(4) 2013. (B)(4) WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO (B)(4) COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    DETAILS OF THE COMPLAINT: QTY : 1 WRONG PRODUCT : AS PER ATTACHED PHOTO, PRINTED "UNOMEDICAL" INSTEAD OF "ENTRASOFT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299981 ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR), 73BTR BTR UNOMEDICAL SDN BHD 61214070 608052R001

    Patients

    Seq Age Sex Outcome Treatment
    1