BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCUFF ENDOTRACHEAL TUBE-PED ORAL/NASALMAG

    MDR report key: 852338 · Received May 18, 2007

    Report

    Report Number
    1033422-2007-00037
    Event Type
    Malfunction
    Date Received
    May 18, 2007
    Report Date
    May 18, 2007
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K050803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO KIMBERLY-CLARK FOR EVALUATION; HOWEVER, AN INVESTIGATION BASED ON THE LOT NUMBER PROVIDED, WILL BE INITIATED. THE DOCTOR REPORTING THIS PRODUCT INCIDENT INDICATED THAT HAVING HAD EXPERIENCE WITH THE PREVIOUS GENERATIONS OF THIS TUBE, HE BELIEVES THAT THE MECHANICAL PROPERTIES OF THE TUBE SEEM TO HAVE CHANGED. THE PRODUCT INCIDENT HAS BEEN INCORPORATED IN THE KIMBERLY-CLARK COMPLAINT TRENDING SYSTEM WHICH IS USED TO IDENTIFY REPETITIVE ISSUES THAT REQUIRE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    THE EXACT DATE OF THIS EVENT IS NOT KNOWN NOR ARE ANY DETAILS PROVIDED ABOUT THE PT OTHER THAN THE FACT THAT THE INCIDENT INVOLVED AN INFANT. THIS IS A REPORT OF ONE OF "SEVERAL LIFE THREATENING COMPLICATIONS WITH THIS KCC-MICROCUFF TUBE" FROM A PEDIATRIC ANESTHESIOLOGIST. THE DOCTOR REPORTED THAT IN THE OPERATING ROOM SETTING, THE ENDOTRACHEAL TUBE KINKED. SINCE RESPIRATORY MONITORING WAS SET PROPERLY, THE KINK WAS DETECTED AND CORRECTED BEFORE ANY DESATURATION OCCURRED TO THE INFANT PT. NO INJURY TO THE PT WAS REPORTED. THE DOCTOR ALSO STATED THAT THE KINKING WAS DUE TO THE FACT THAT THE INFANT WAS "COMPLETELY COVERED." KIMBERLY-CLARK HAS NOT INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED ABOVE BUT IS RELAYING THE INFO THAT WAS PROVIDED BY THE FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROCUFF ENDOTRACHEAL TUBE-PED ORAL/NASALMAG ENDOTRACHEAL TUBE, CUFFED BTR UNOMEDICAL SDN BHD NA UM6266 (691835R001)

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention