BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROCUFF ENDOTRACHEAL TUBE (ADULT)

    MDR report key: 1016376 · Received March 12, 2008

    Report

    Report Number
    1033422-2008-00002
    Event Type
    Other
    Date Received
    March 12, 2008
    Date of Event
    December 4, 2007
    Report Date
    March 11, 2008
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, A FOLLOW-UP REPORT WILL BE PROVIDED WHEN ADDITIONAL RELEVANT INFO BECOMES AVAILABLE. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT & MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFO IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR BY KC SALES REP THAT AFTER INTUBATING A PEDIATRIC PT WITH A 5.5 MM ET TUBE AND SEALING IT TO THE APPROPRIATE DEPTH MARKING TO THE VOCAL CORDS AS RECOMMENDED, A DOCTOR NOTICED THAT THE TUBE WAS TOO FAR OUT. THE TUBE WAS READJUSTED AND THE ACTUAL DEPTH MARKING WAS FOUND TO BE HIGHER THAN WHAT WAS RECOMMENDED. THE USER CLAIMS THAT WHEN THE TUBE IS TOO FAR OUT, THERE IS RISK OF EXTUBATION AND HAVING THE CUFF IN THE VOCAL CORDS. THERE WAS NO REPORT OF SERIOUS INJURY OR DEATH AS A RESULT OF THE DEPTH MARKING STATED TO BE LOW. IT MUST BE NOTED THAT AN ADULT MICROCUFF, NOT A PEDIATRIC MICROCUFF, WAS USED ON A PEDIATRIC PT. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED, BUT IS RELAYING THE INFO THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROCUFF ENDOTRACHEAL TUBE (ADULT) ENDOTRACHEAL TUBE BTR UNOMEDICAL SDN BHD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR