BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 340 SW, 340 ML W/040 ADAPTOR

    MDR report key: 3950615 · Received June 5, 2014

    Report

    Report Number
    1417411-2014-00042
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 30, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED. A REVIEW OF MANUFACTURING EVENT LOG SHOWS NO ISSUES THAT MAY HAVE CONTRIBUTED TO ANY QUALITY ISSUES REPORTED. ALL PROCESS PARAMETERS WERE WITHIN SPECIFICATION. ALL IN-PROCESS QA INSPECTIONS WERE ACCEPTABLE. NO SAMPLE AVAILABLE FROM THE CUSTOMER TO INVESTIGATE. THE COMPLAINT IS NOT CONFIRMED. ROOT CAUSE UNK. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK FROM THE CUSTOMERS ON ISSUES RELATED TO WATER BOTTLE GETTING CRACKED PRIOR TO OR DURING USE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE BOTTOM OF THE BOTTLE (DEVICE) CRACKED DURING USE. PT CONDITION REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328728 HUDSON AQUAPAK 340 SW, 340 ML W/040 ADAPTOR BUBBLE HUMIDIFIER BTT TELEFLEX MEDICAL 044137

    Patients

    Seq Age Sex Outcome Treatment
    1