BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON MASK,MULTI-VENT,ADULT

    MDR report key: 6990305 · Received October 31, 2017

    Report

    Report Number
    3004365956-2017-00376
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    October 23, 2017
    Report Date
    October 23, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BYF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PHYSICAL DEVICE SAMPLE HAS NOT BEEN RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT WAS PERFORMED ON PICTURES PROVIDED BY THE CUSTOMER. IT CAN BE OBSERVED A FOREIGN PARTICLE THAT LOOKS LIKE AN INSECT INSIDE THE TUBING, AND ALSO. NO OTHER ISSUES WERE FOUND. THE DHR REVIEWED SHOWED THAT THERE WERE NO ISSUES RELATED TO THE REPORTED FAILURE MODE NEITHER ON THE PRODUCT NOR ITS COMPONENTS DURING THE MANUFACTURE OF THIS MATERIAL. CUSTOMER COMPLAINT IS CONFIRMED BASED ON THE VISUAL INSPECTION PERFORMED TO THE PICTURES PROVIDED BY THE CUSTOMER. HOWEVER, IT IS NOT POSSIBLE TO DETERMINE WHERE ON THE DISTRIBUTION CHAIN OF THE PRODUCT THE INSECT GOT INSIDE THE TUBING. ALTHOUGH THE COMPLAINT IS CONFIRMED, THERE IS NOT SUFFICIENT EVIDENCE THAT THIS ISSUE ORIGINATED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE FOR THE CONDITION REPORTED COULD NOT BE IDENTIFIED. TELEFLEX (B)(4) HAS PEST CONTROL SYSTEM TO AVOID CONTAMINATION BY INSECTS IN OUR PRODUCTS. A CONCLUSION CODE COULD NOT BE FOUND AS THE COMPLAINT WAS CONFIRMED BUT A ROOT CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "BEFORE USING THE PRODUCT, A CUSTOMER FOUND SOMETHING THAT LOOKED LIKE A WORM IN THE LINE OF THE PRODUCT." CUSTOMER SUBMITTED PHOTOS FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771674 HUDSON MASK,MULTI-VENT,ADULT MASK, OXYGEN, LOW CONCENTRATIO BYF TELEFLEX MEDICAL 74C1700492

    Patients

    Seq Age Sex Outcome Treatment
    1