BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE

    MDR report key: 5019383 · Received August 20, 2015

    Report

    Report Number
    3004365956-2015-00264
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 7, 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). NO VISUAL OR DIMENSIONAL INSPECTION CAN BE PERFORMED SINCE THE DEVICE SAMPLE IS NOT AVAILABLE FOR EVALUATION. NO FUNCTIONAL INSPECTION CAN BE PERFORMED SINCE THE DEVICE SAMPLE IS NOT AVAILABLE FOR EVALUATION. FAILURE MODE COULD NOT BE DUPLICATED SINCE IT IS UNKNOWN THE REASON THE ADAPTOR IS NOT FITTING CORRECTLY TO THE OXYGEN FLOW METER, HOWEVER FUNCTIONAL TEST WAS PERFORMED ON 30 SUBASSEMBLY (P/N: 12161) & NO ISSUES OR DISCREPANCIES WERE FOUND. THE TEST CONSISTED OF 30 PIECES FROM THE PROCESS, VISUAL INSPECTION AND OXYGEN FLOWMETER WAS USED WITH THE SAMPLES AND IT WAS FOUND THEY PERFORMED ACCORDING TO SPECIFICATION. A DHR (DEVICE HISTORY RECORD) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. BASED ON SIMILAR COMPLAINTS A CAPA FILE# (B)(4) WAS OPENED TO FURTHER INVESTIGATE THIS ISSUE. NO CONCLUSION CAN BE ESTABLISHED AT THIS TIME BASED ON THE LACK OF DEVICE SAMPLE. IF THE DEVICE SAMPLE BECOMES AVAILABLE THIS COMPLAINT WILL BE REOPENED.

    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. OXYGEN ENTRAINMENT TESTING COULD NOT BE PERFORMED AS THE ADAPTOR COULD NOT BE CONNECTED CORRECTLY ON THE OXYGEN SUPPLY DUE THE DAMAGE ON THE INTERNAL THREAD. 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.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE ADAPTOR DIDN'T FIT WITH THE OXYGEN FLOWMETER. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE ADAPTOR DIDN'T FIT WITH THE OXYGEN FLOWMETER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551724 HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE ADAPTOR CAF TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1