BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE HOLDER, STANDARD

    MDR report key: 9706387 · Received February 13, 2020

    Report

    Report Number
    8040412-2020-00047
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    January 28, 2020
    Report Date
    January 28, 2020
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THE MANUFACTURER REPORTS THAT THE SUPPLIER (POWER CHOICE) HAD "CARRIED OUT THE STATIC TEST (SAMPLING CHECK) AS PER THE ASTM 2726 FOR EACH LOT THAT PRODUCED. THERE IS NO LOTS REJECTED IN-HOUSE DUE TO THE SAME ISSUE AS REPORTED BY COMPLAINANT. HOWEVER BOTH TELEFLEX AND POWER CHOICE ARE WELL AWARE OF ISSUES REPORTED AND AS PROACTIVE ACTION, CURRENTLY RESEARCH AND DEVELOPMENT GROUP FROM TELEFLEX MORRISVILLE, USA IS WORKING WITH THE SUPPLIER ON THE IMPROVEMENT FOR THE CHEEK PAD.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE UPPER LIP STABILIZER FELL OFF AND PATIENT EXPERIENCED SKIN BREAKDOWN DUE TO USE OF DEVICE WITHOUT THE LIP STABILIZER. NO TREATMENT OR INTERVENTION WAS REPORTED FOR THE SKIN BREAKDOWN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE UPPER LIP STABILIZER FELL OFF AND PATIENT EXPERIENCED SKIN BREAKDOWN DUE TO USE OF DEVICE WITHOUT THE LIP STABILIZER. NO TREATMENT OR INTERVENTION WAS REPORTED FOR THE SKIN BREAKDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170498 HUDSON ET TUBE HOLDER, STANDARD TRACHEAL TUBE FIXATION DEVICE CBH TELEFLEX MEDICAL SDN. BHD. UNKNOWN

    Patients

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