BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,

    MDR report key: 5469885 · Received March 1, 2016

    Report

    Report Number
    3004365956-2016-00140
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    February 12, 2016
    Report Date
    February 15, 2016
    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). ONE UNIT OF SUBASSEMBLY (B)(4) INTL NEB ADAPTOR PHANTOM HOLDER WAS RECEIVED FOR ANALYSIS. THIS SUBASSEMBLY COULD BE PART OF THE (B)(4) NEBULIZER ADAPTOR 028, STERILE, SHELFPAK, RELATED TO THIS CUSTOMER COMPLAINT. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THERE WERE DAMAGES ON THE INTERNAL THREAD OF THE ADAPTOR. IT WAS ALSO OBSERVED THAT THE TUBING HAD A CUT ON ONE END. NO OTHER ISSUES WERE FOUND. A DUAL STATION LIFT TEST WAS PERFORMED; HOWEVER, IT WAS NOT POSSIBLE TO PERFORM THE GENERAL PULL AND PUSH TEST PROCEDURES DUE TO THE CUT ON THE TUBING. ALSO, OXYGEN ENTRAINMENT TESTING COULD NOT BE PERFORMED AS THE ADAPTOR COULD NOT BE CONNECTED CORRECTLY TO THE OXYGEN SUPPLY DUE TO THE DAMAGE ON THE INTERNAL THREAD. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. THE ROOT CAUSE FOR THE ISSUE WAS FOUND TO BE 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). CONCLUSION(S) - A CONCLUSION CODE COULD NOT BE CHOSEN. THE COMPLAINT WAS CONFIRMED, VIA PHOTO, BUT THE ROOT CAUSE IS UNKNOWN. ONE PICTURE WAS RECEIVED FOR ANALYSIS. DURING THE VISUAL INSPECTION IT WAS OBSERVED DAMAGE ON THE INTERNAL THREAD OF THE COMPONENT P/N MP-0321. NO OTHER ISSUES WERE FOUND. A DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. DURING THE VISUAL INSPECTION ON THE RECEIVED PICTURE IT WAS FOUND DAMAGE ON THE INTERNAL THREAD OF THE COMPONENT P/N MP-0321, THEREFORE, CUSTOMER COMPLAINT IS CONFIRMED. REGARDING OTHER CUSTOMER COMPLAINTS DUE TO THE SAME ISSUE, A CAPA FILE #(B)(4) WAS OPENED TO PERFORM A FURTHER INVESTIGATION INTO THIS ISSUE (THIS CAPA IS OWNED BY(B)(4)). 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. ADDITIONALLY, THE PERSONNEL OF THE ASSEMBLY LINE WERE NOTIFIED AND MADE AWARE OF THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE ADAPTOR CONNECTOR IS BROKEN (SCREW THREADS ARE STRIPPED) AND UNABLE TO CONNECT TO THE AQUAPAK.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE ADAPTOR CONNECTOR IS BROKEN (SCREW THREADS ARE STRIPPED) AND UNABLE TO CONNECT TO THE AQUAPAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127921 HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK, NEBULIZER CAF TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1