BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACH CARE DBL SWV ELBOW ENDO 12FR 20

    MDR report key: 3981276 · Received August 5, 2014

    Report

    Report Number
    8030647-2014-00015
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 10, 2014
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BSY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION BUT 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 COMPLAINT (B)(4). DEVICE NOT RETURNED BY CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM (B)(6) STATING, IT WAS NOTICED THAT THE END OF THE SUCTION CATHETER WAS MISSING AFTER REGULAR CHECKS. THE ENDOTRACHEAL TUBE WAS CUT PRIOR TO INSERTION OF THE SUCTION TUBE AND THEREFORE CANNOT HAVE RESULTED IN THE SEVERANCE OF THE TIP. THE TIP OF THE SUCTION CATHETER WAS RETRIEVED ON BRONCHOSCOPY BY AN ANESTHETIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457860 TRACH CARE DBL SWV ELBOW ENDO 12FR 20 CLOSED SUCTION CATHETER BSY KIMBERLY-CLARK HEALTH CARE 2160-5 M3156T619

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR