BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACH CARE WETPAK DBL SWV ELBOW ENDO 12FR 20

    MDR report key: 6118368 · Received November 21, 2016

    Report

    Report Number
    9611594-2016-00170
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 5, 2016
    Report Date
    December 5, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    BSY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. THE DEVICE HISTORY RECORD FOR (B)(4) 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 COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ONE USED SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION UNDER UV LIGHT REVEALED INCONSISTENT ADHESIVE COVERAGE ON THE CATHETER. NO ROOT CAUSE HAS BEEN IDENTIFIED AT THIS TIME. ACTIONS HAVE BEEN TAKEN TO ELIMINATE THE REPORTED FAILURE MODE AND ADDITIONAL INVESTIGATIONS ARE BEING PERFORMED TO ATTAIN A ROOT CAUSE AND IMPLEMENT NEW CORRECTIVE AND PREVENTIVE ACTIONS. 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). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUCTION CATHETER BECAME DETACHED FROM THE PORT WHILE IN USE ON A PATIENT. IT WAS IMMEDIATELY REMOVED AND REPLACED WITH A NEW ONE. NO INJURY TO THE PATIENT WAS REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768757 TRACH CARE WETPAK DBL SWV ELBOW ENDO 12FR 20 CLOSED SUCTION KIMVENT ADULT STD USE BSY HALYARD HEALTH 21606-5 M5159T634

    Patients

    Seq Age Sex Outcome Treatment
    1