BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TC-72 12FR DSE

    MDR report key: 5784138 · Received July 11, 2016

    Report

    Report Number
    8030647-2016-00134
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    June 12, 2016
    Report Date
    August 12, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    BSY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR M5336T309 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. HALYARD HEALTH 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS (B)(4).

    Additional Manufacturer Narrative · 1

    ONE USED HALYARD SUCTION CATHETER SAMPLE WAS RECEIVED WITHOUT ORIGINAL PACKAGING. RECEIVED WITH THE SAMPLE WAS THE CATHETER MOUNT (AN INTERSURGICAL PRODUCT). THE SAMPLE APPEARED TO BE IN GENERALLY CLEAN CONDITION. THE CONNECTION OF THE MATING COMPONENTS WAS CHECKED. THE CONNECTION OF THE HYH FLEX CONNECTOR TO THE DOUBLE SWIVEL ELBOW MALE INSERT (DSE) DOES NOT DISPLAY ANY CONNECTION ISSUE. THE CONNECTION OF THE HYH FLEX CONNECTOR TO THE RETURNED INTERSURGICAL FLEX CONNECTOR DOES NOT DISPLAY ANY CONNECTION ISSUE. THE EVALUATION OF THE RETURNED SAMPLE DID NOT CONFIRM FAILURE REPORTED, THEREFORE A PROPER ROOT CAUSE HAS NOT BEEN IDENTIFIED. HALYARD HEALTH 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOOSE CONNECTION BETWEEN THE DOUBLE SWIVEL ELBOW MALE CONNECTOR AND THE FLEX STRAIGHT CATHETER MOUNT. THIS WAS FOUND DURING THE SECOND SUCTION. THE DEVICE WAS REPLACED WITHOUT ANY ISSUES. NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438265 TC-72 12FR DSE CLOSED SUCTION KIMVENT TURBOCLEAN ADULT BSY HALYARD HEALTH 22716-4J M5336T309

    Patients

    Seq Age Sex Outcome Treatment
    1