BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH CARLENS DOUBLE LUMEN BRONCHIAL TUBE

    MDR report key: 10400906 · Received August 13, 2020

    Report

    Report Number
    8040412-2020-00168
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 29, 2020
    Report Date
    July 30, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTS
    PMA / PMN Number
    K951091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE ACTUAL SAMPLE INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION; THEREFORE, A REPRESENTATIVE SAMPLE WAS TAKEN FROM CURRENT PRODUCTION AT THE MANUFACTURING FACILITY. A VISUAL EXAM WAS PERFORMED ON THE REPRESENTATIVE SAMPLE AND NO DEFECTS WERE OBSERVED. THE BRONCHIAL CUFF AND THE TRACHEAL CUFF WERE THEN INFLATED TO 25MBAR USING A CALIBRATED ENDOTEST. THE CUFFS WERE INFLATED AND DEFLATED WITH NO ISSUES. THE SAMPLE WAS THEN IMMERSED IN WATER TO CHECK FOR LEAKS. NO BUBBLES WERE OBSERVED COMING FROM THE CUFFS INDICATING THERE WERE NO LEAKS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. ALTHOUGH THERE WERE NO ISSUES FOUND WITH THE PRODUCTION SAMPLE, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ACTUAL SAMPLE IS NEEDED TO PERFORM A PROPER INVESTIGATION AND DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT REPORTED AS: "AT THE TIME OF THE INTUBATION, AFTER INSERTION OF THE TUBE, THE ATTEMPT TO INFLATE THE CUFF FAILED, AS THE CUFF DIDN'T KEPT THE PRESSION IN THE TRACHEA. THE CUFF HAD BEEN TESTED FOR LEAK PRIOR TO USE. 3 TUBES USED, 3 FAILURES. THE TUBES HAVE BEEN REMOVED AND A 4TH TUBE OF ANOTHER LOT NUMBER WAS FINALLY SUCCESSFULLY USED. CLINICAL CONSEQUENCES: DELAY IN PATIENT'S CARE DURING A SENSITIVE PROCEDURE." IT WAS REPORTED THAT THE PATIENT HAD A PROCEDURE ON THE ESOPHAGUS. THE PATIENT'S CONDITION WAS REPORTED AS "FINE".

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT REPORTED AS: "AT THE TIME OF THE INTUBATION, AFTER INSERTION OF THE TUBE, THE ATTEMPT TO INFLATE THE CUFF FAILED, AS THE CUFF DIDN'T KEPT THE PRESSION IN THE TRACHEA. THE CUFF HAD BEEN TESTED FOR LEAK PRIOR TO USE. 3 TUBES USED, 3 FAILURES. THE TUBES HAVE BEEN REMOVED AND A 4TH TUBE OF ANOTHER LOT NUMBER WAS FINALLY SUCCESSFULLY USED. CLINICAL CONSEQUENCES: DELAY IN PATIENT'S CARE DURING A SENSITIVE PROCEDURE." IT WAS REPORTED THAT THE PATIENT HAD A PROCEDURE ON THE ESOPHAGUS. THE PATIENT'S CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866334 RUSCH CARLENS DOUBLE LUMEN BRONCHIAL TUBE TUBE, BRONCHIAL (W/WO CONNECT BTS TELEFLEX MEDICAL IPN047057 18HT31

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.| NONE REPORTED.