BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE

    MDR report key: 4898234 · Received July 8, 2015

    Report

    Report Number
    3004365956-2015-00179
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 22, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE WAS RECEIVED BY THE MANUFACTURER, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. THE DEVICE HISTORY RECORD OF THE PRODUCT 031-33J WITH BATCH NUMBER 74B1503150 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. MANUFACTURING ((B)(4)) AND QUALITY INSPECTION ((B)(4)) PROCEDURES AND PROCESSES WERE REVIEWED AND SHOWED THAT PROPER CONTROLS ARE IN PLACE TO GUARANTEE THAT ACCEPTABLE PRODUCT IS DELIVERED TO OUR CUSTOMERS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE THREAD OF THE ADAPTOR WAS DAMAGED. BASED ON THE VISUAL EXAM, THE REPORTED COMPLAINT WAS CONFIRMED. ALL PERSONNEL FROM THE MOLDING AREA RELATED TO THIS PROCESS WERE NOTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT AN AIR LEAK OCCURRED BECAUSE THE ADAPTOR DIDN'T FIT WITH THE OXYGEN FLOW METER.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT AN AIR LEAK OCCURRED BECAUSE THE ADAPTOR DIDN'T FIT WITH THE OXYGEN FLOW METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443769 HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE ADAPTOR CAF TELEFLEX MEDICAL 74B1503150

    Patients

    Seq Age Sex Outcome Treatment
    1