BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH CARLENS DOUBLE LUMEN BRONCHIAL TUBE

    MDR report key: 10400890 · Received August 13, 2020

    Report

    Report Number
    8040412-2020-00169
    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

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND A LEAK WAS FOUND AT THE CUFF AREA. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE INVESTIGATION PERFORMED, THE COMPLAINT WAS CONFIRMED. THE AFFECTED LOT WAS MANUFACTURED IN AUGUST 2015 AND EVENT DATE WAS ON (B)(6) 2020. THE EXPIRY DATE FOR THIS PRODUCT AS PER MENTIONED ON LABEL WAS 28 JUL 2020.

    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 SUCCESULLY 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
    866038 RUSCH CARLENS DOUBLE LUMEN BRONCHIAL TUBE TUBE, BRONCHIAL (W/WO CONNECT BTS TELEFLEX MEDICAL IPN047057 15HT22

    Patients

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