BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT 8.5MM ET TUBE WITH SUBGLOTTIC SUCTIONING

    MDR report key: 3961562 · Received July 28, 2014

    Report

    Report Number
    9611594-2014-00062
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    June 30, 2014
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BTR
    PMA / PMN Number
    PK131254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT SAMPLE WITHOUT PACKAGING AND TWO UNUSED SAMPLES WITH PACKAGING WERE RETURNED FOR EVALUATION. ONE UNUSED SAMPLE WAS OPENED AND ONE WAS UNOPENED. THE ACTUAL COMPLAINT SAMPLE WAS EVALUATED. THE BLUE INFLATION LINE WAS DETACHED FROM THE ET TUBE. THE INFLATION LINE WAS EXAMINED, AND A VISIBLE CLUMP OF ADHESIVE WAS LOCATED 1CM FROM THE DISTAL END OF THE LINE. THE ET TUBE WAS EXAMINED, AND ADHESIVE RESIDUE WAS VISIBLE AROUND THE OPENING AT THE CONNECTION POINT FOR THE INFLATION LINE; HOWEVER, NO FLUORESCENCE WAS DETECTABLE UNDER UV LIGHT THE OPENED UNUSED SAMPLE, WHICH WAS IN A PACKAGE WITH LOT # AA3260V01, WAS EVALUATED. THE INFLATION LINE APPEARED PARTIALLY INSERTED INTO THE ET TUBE CONNECTION AND IT EASILY SEPARATED FROM THE ET TUBE. AS THE PACKAGE WAS ALREADY OPENED, IT WAS NOT KNOWN WHETHER THE INFLATION LINE WAS PREVIOUSLY SEPARATED. A VISIBLE CLUMP OF ADHESIVE WAS VISUALLY DETECTED 1CM FROM THE DISTAL END OF THE LINE. THE ET TUBE WAS EXAMINED, AND VISIBLE ADHESIVE RESIDUE WAS VISIBLE AROUND THE OPENING AT THE CONNECTION POINT FOR THE INFLATION LINE; HOWEVER, NO FLUORESCENCE WAS DETECTABLE UNDER UV LIGHT. THE UNOPENED SAMPLE, WHICH WAS LABELED WITH LOT AA3260V01, WAS EVALUATED. THE INFLATION LINE REMAINED ATTACHED TO THE ET TUBE. VISUAL EXAMINATION UNDER UV LIGHT IDENTIFIED NO DETECTABLE FLUORESCENCE AT THE ET TUBE/INFLATION LINE JUNCTION. PULL TESTING OF THE INFLATION-LINE TO ET-TUBE-CONNECTION WAS PERFORMED USING ESTABLISHED PROCEDURES, AND THE TEST RESULT FOR PULL FORCE MET SPECIFICATIONS. THE DEVICE HISTORY RECORDS (DHR) REVIEW FOR THE LOT NUMBER REPORTED/IDENTIFIED INDICATES THAT THE DEVICE LOT WAS MANUFACTURED ACCORDING TO MANUFACTURING REQUIREMENTS. THIS ASSESSMENT DID NOT REVEAL ANY REJECTIONS RELATED TO THE REPORTED ISSUE. NO UPWARD TREND WAS OBSERVED ON THIS REPORTED INCIDENT. THE COMPLAINT TREND FOR THE PAST 8 MONTHS WAS REVIEWED BY DEVICE MANUFACTURING DATE, AND THE INCIDENCE RATE FOR THIS TYPE OF EVENT, WHICH IS CALCULATED USING THE QUANTITY OF CONFIRMED INCIDENCES, REMAINS WITHIN THE ACCEPTABLE RANGE DEFINED IN THE PREVIOUSLY ESTABLISHED RISK MANAGEMENT PLAN. ROOT CAUSE COULD NOT BE DETERMINED. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED COMPLAINT PRODUCT AND REVIEW OF THE DEVICE HISTORY RECORDS ARE IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS (B)(4).

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS INVOLVING TWO DEVICES USED DURING THE SAME PROCEDURE ON THE SAME PATIENT. REFER TO MFG. REPORT # 9611594-2014-00063 FOR THE SECOND REPORT. KIMBERLY-CLARK RECEIVED A REPORT FROM (B)(6) STATING, "CUSTOMER COMPLAINED THAT THE TUBE TO INFLATE THE CUFF OF OUR MICROCUFF SUBGLOTTIC TUBE COME OFF TWICE AT ONE PATIENT. FIRST THEY THOUGHT THAT THE PATIENT HAS BITTEN THE LINE OFF, BUT AFTER DETAILED INVESTIGATION OF THE CUSTOMER, THEY SAID THAT THIS IS NOT POSSIBLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439270 ADULT 8.5MM ET TUBE WITH SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE BTR KIMBERLY-CLARK HEALTH CARE 13223 AA3260V01

    Patients

    Seq Age Sex Outcome Treatment
    1