BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE

    MDR report key: 5101032 · Received September 24, 2015

    Report

    Report Number
    3004365956-2015-00293
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 10, 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 SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE INTERNAL THREADS OF THE ADAPTOR WERE DAMAGED. THE DAMAGE ON THE INTERNAL THREAD OF THE ADAPTOR WAS NOT ACCEPTABLE ACCORDING TO CURRENT SPECIFICATIONS; HOWEVER THE SAMPLE WAS ABLE TO BE CONNECTED TO AN OXYGEN SOURCE AND OXYGEN ENTRAINMENT TESTING WAS ABLE TO BE PERFORMED. BASED ON THE VISUAL EXAM, THE REPORTED COMPLAINT WAS CONFIRMED. THE ROOT CAUSE FOR THE ISSUE IS THE POSITIONING OF THE THREAD LEAD AND THE SOFTNESS OF THE NEW RESIN USED FOR THE SNAP ADAPTOR. A CAPA WAS OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). NO VISUAL, FUNCTIONAL OR DIMENSIONAL INSPECTION CAN BE PERFORMED SINCE THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD REVIEW SHOWED THAT THERE WERE NO ISSUES RELATED TO FUNCTIONAL ISSUES NEITHER ON THE PRODUCT NOR ITS COMPONENTS DURING THE MANUFACTURE OF THE MATERIAL. BASED ON SIMILAR COMPLAINTS A CAPA FILE (B)(4) WAS OPENED TO FURTHER INVESTIGATE THIS ISSUE. ACCORDING TO THE CAPA INVESTIGATION SO FAR THE ROOT CAUSE FOR THE ISSUE WAS THE POSITIONING OF THE THREAD LEAD AND THE SOFTNESS OF THE NEW RESIN USED FOR THE SNAP ADAPTOR. NO CONCLUSION CAN BE ESTABLISHED AT THIS TIME BASED ON THE LACK OF DEVICE OF SAMPLE. IT IS NECESSARY TO HAVE PHYSICAL SAMPLE IN ORDER TO PERFORM A PROPER INVESTIGATION. IF THE DEVICE SAMPLE BECOMES AVAILABLE THIS COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE USER WAS NOT ABLE TO CONNECT THE NEBULIZER ADAPTOR WITH THE FLOW METER. THE SCREW-THREAD CONNECTOR WAS STRIPPED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE USER WAS NOT ABLE TO CONNECT THE NEBULIZER ADAPTOR WITH THE FLOW METER. THE SCREW-THREAD CONNECTOR WAS STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631484 HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE ADAPTOR CAF TELEFLEX MEDICAL 74D1500992

    Patients

    Seq Age Sex Outcome Treatment
    1