BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSAN INFANT NASAL CPAP CANNULA, SIZE 3

    MDR report key: 4163188 · Received July 16, 2014

    Report

    Report Number
    3004365956-2014-00251
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 30, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BZD
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT PROVIDE ANY ADD'L INFO REGARDING THE OUTCOME OF "BLISTER ON THE UPPER LIP DURING USE". THE CONDITION OF THE PT WAS REPORTED AS FINE. UNK IF THIS WAS AN ADVERSE EVENT AND/OR A PRODUCT PROBLEM. A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT OR A PICTURE OF THE DEFECT WAS NOT PROVIDED. THE DHR (DEVICE HISTORY RECORD) WAS REVIEWED AND SHOWED THAT THERE WERE NO ISSUES RELATED TO THIS ISSUE NEITHER ON THE PRODUCT NOR ITS COMPONENTS DURING THE MANUFACTURE OF THE MATERIAL. NO NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. THE DHR SHOWED THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECS. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFO PROVIDED, IN ORDER TO PERFORM A PROPER INVESTIGATION IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THE INCIDENT. IF THE DEFECTIVE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVAL RESULTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT A BABY DEVELOPED BLISTERS ON THE UPPER LIP DURING CPAP. THE PT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416902 HUDSAN INFANT NASAL CPAP CANNULA, SIZE 3 UNFANT NASAL CPAP BZD TELEFLEX 02B1300134

    Patients

    Seq Age Sex Outcome Treatment
    1