BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON MULTI-VENT MASK, ADULT

    MDR report key: 3252515 · Received July 24, 2013

    Report

    Report Number
    3004365956-2013-00242
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 3, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT WAS CONDUCTED BASED ON THE PICTURES FROM THE CUSTOMER. FROM THE PHOTO, AN INSECT CAN BE OBSERVED ON THE TUBING, BUT IT IS NOT POSSIBLE TO DETERMINE IN WHICH PART OF THE SUPPLY CHAIN PROCESS THE MATERIAL IS BEING CONTAMINATED, HOWEVER, TELEFLEX (B)(4) HAS A PEST CONTROL SYSTEM TO AVOID CONTAMINATION BY INSECTS IN OUR PRODUCTS. A DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DHR (DEVICE HISTORY RECORD) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. AT PRESENT TIME IT IS NOT POSSIBLE TO DETERMINE IN WHICH PART OF THE SUPPLY CHAIN PROCESS THE MATERIAL IS BEING CONTAMINATED, HOWEVER, TELEFLEX (B)(4) HAS A PEST CONTROL SYSTEM TO AVOID CONTAMINATION BY INSECTS IN OUR PRODUCTS. THE COMPLAINT IS CONFIRMED ACCORDING TO THE PICTURE RECEIVED, THE INSECT MENTIONED ON THE COMPLAINT CAN BE OBSERVED INSIDE THE TUBING, THE CONTAMINATION COULD OCCUR ALSO DURING THE PREPARATION STAGES PREVIOUS TO THE USE OF THE NEBULIZER AND NOT BEING DETECTED UNTIL IT WAS PUT IN TO FUNCTION. AT PRESENT TIME, THE (B)(4) FACILITY HAS A PEST CONTROL SYSTEM WITH THE PURPOSE TO AVOID AND ELIMINATE POSSIBLE CONTAMINATION SOURCES THAT COULD INVOLVE INSECTS, ALSO THERE IS THE POSSIBILITY THAT THE CONTAMINATION HAPPENED ON ACTIVITIES AFTER THE PRODUCTION OF THE MATERIAL ON THE (B)(4) FACILITY AND PREVIOUS TO THE DELIVERY TO THE CUSTOMER (TRANSPORT, STORAGE OR DELIVERY).

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE CUSTOMER REPORTS THAT DURING THE UNFOLDING OF THE PACK AND CONNECTING DUCT, THE NURSE FOUND AN INSECT INSIDE THE CANNULA OF THE OXYGEN AND AEROSOL MASK PRIOR TO USE ON A PT. NO REPORT OF A PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345642 HUDSON MULTI-VENT MASK, ADULT OXYGEN MASK BYG TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1