BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SILENT HUMIDIFIER ADAPTOR 011

    MDR report key: 3950633 · Received June 5, 2014

    Report

    Report Number
    1417411-2014-00043
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 27, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE DISTRIBUTOR ALLEGES THAT DURING INCOMING INSPECTION A PINHOLE WAS FOUND ON THE PACKAGE. THE DISTRIBUTOR ((B)(4) DISTRIBUTOR) REPORTS A TOTAL OF SIXTEEN (16) PACKAGES WITH THE ALLEGED DEFECT OF PINHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329672 HUDSON SILENT HUMIDIFIER ADAPTOR 011 HUMIDIFIER ADAPTOR BTT TELEFLEX MEDICAL K01311

    Patients

    Seq Age Sex Outcome Treatment
    1