BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ADAPTOR,028 NEB,INTL

    MDR report key: 5229248 · Received November 17, 2015

    Report

    Report Number
    3004365956-2015-00352
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    October 29, 2013
    Report Date
    October 29, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THREE PICTURES WERE RECEIVED FOR ANALYSIS. DURING THE VISUAL INSPECTION, TWO PICTURES SHOW THE SUBASSEMBLY P/N 12161 ASSEMBLED WITH AN AQUAPAK STERILE WATER BOTTLE AND CONNECTED TO THE OXYGEN SUPPLY. ONE PICTURE SHOW ONLY THE SUBASSEMBLY P/N 12161 CONNECTED TO THE OXYGEN SUPPLY. ON THE 3 PICTURES IT CAN BE OBSERVED THAT THE COMPONENT P/N MP-0321 CANNOT BE CONNECTED CORRECTLY ON THE OXYGEN SUPPLY. NO OTHER ISSUES WERE FOUND. NO FUNCTIONAL INSPECTION CAN BE PERFORMED SINCE THE DEVICE SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, AS AN ADDITIONAL TEST, OXYGEN ENTRAINMENT TESTING (B)(4) WAS PERFORMED TO 30 SUBASSEMBLY (P/N: 12161) PRODUCTION SAMPLES THAT WERE TAKEN RANDOMLY FROM ADAPTORS ASSEMBLY LINE. THESE COMPONENTS ARE PART OF CATALOG NUMBER 30228 BATCH 74L1500416. DURING THE TESTING AND VISUAL INSPECTION NO ISSUES OR DISCREPANCIES WERE FOUND THAN CAN LEAD TO THE CONDITION REPORTED BY THE CUSTOMER. AS AN ADDITIONAL TEST, ONE OF THE SUBASSEMBLY P/N 12161 PRODUCTION SAMPLE WAS ASSEMBLED WITH A STERILE WATER CONCHA MINI BOTTLE AND TESTED ACCORDING OXYGEN ENTRAINMENT TESTING. OTHER REMARKS: DURING THE TESTING NO ISSUES OR DISCREPANCIES WERE FOUND THAT CAN LEAD TO THE CONDITION REPORTED BY THE CUSTOMER. THE DEVICE HISTORY RECORD OF THE PRODUCT 30228 BATCH NUMBER 74C1503625 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. DURING THE VISUAL INSPECTION ON THE PICTURES RECEIVED IT CAN BE OBSERVED THAT THE COMPONENT P/N MP-0321 CANNOT BE CONNECTED CORRECTLY ON THE OXYGEN SUPPLY, 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 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 IN ORDER TO KEEP THEM AWARE OF THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE ADAPTOR WOULD NOT ATTACH TO THE FLOWMETER.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE ADAPTOR WOULD NOT ATTACH TO THE FLOWMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760276 HUDSON ADAPTOR,028 NEB,INTL NEBULIZER CAF TELEFLEX MEDICAL 74C1503625

    Patients

    Seq Age Sex Outcome Treatment
    1