BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACH CARE 12FR SDE

    MDR report key: 4360442 · Received December 19, 2014

    Report

    Report Number
    8030647-2014-00034
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    November 17, 2014
    Report Date
    November 21, 2014
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. (B)(6) 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 (B)(6).

    Description of Event or Problem · 1

    (B)(6) RECEIVED A REPORT FROM (B)(6) STATING THERE WAS A LEAK ON THE DUAL SWIVEL ELBOW OF THE CLOSED SUCTION CATHETER DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED IN REGARDS TO THE PATIENT'S STATUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838331 TRACH CARE 12FR SDE TRACH CARE CATHETER BSY HALYARD HEALTH, INC. 2160-4J M4146T625

    Patients

    Seq Age Sex Outcome Treatment
    1