BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 301 SW,340 ML,INTL

    MDR report key: 5110546 · Received September 29, 2015

    Report

    Report Number
    1417411-2015-00160
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 22, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)46. )A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RECEIVED AT OUR FACILITY. BASED ON THE LOT 432147 PROVIDED FOR WHICH THE DHR RESIDES AT (B)(4), THE (B)(4) LOT NUMBERS FOR COMPONENT MP-0321 WERE OBTAINED. RECORDS REVIEWED SHOWED THAT THERE WERE NO ISSUES RELATED TO FUNCTIONAL ISSUES ON THE MOLDED COMPONENT INVOLVED IN THIS COMPLAINT MP-0321 (SNAP-ON FLOWMETER ADAPTOR) BATCH # 4-091422, 5-091421, 5-091422, 6-091421, 6-091422, 7-091421 & 7-091422 DURING THE MANUFACTURE OF THE MATERIAL. CUSTOMER COMPLAINT CANNOT BE CONFIRMED, BASED ONLY ON THE INFORMATION PROVIDED, TO PERFORM A CORRECT INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THIS COMPLAINT. REGARDING OTHER CUSTOMER COMPLAINTS FROM THIS SAME ISSUE, A CAPA FILE #(B)(4) WAS OPENED TO PERFORM A FURTHER INVESTIGATION FOR 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. IF DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE RE-OPENED.

    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. 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 BUBBLING WHEN CONNECTED BETWEEN THE SNAP CAP AND THE OXYGEN OUTLET.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES BUBBLING WHEN CONNECTED BETWEEN THE SNAP CAP AND THE OXYGEN OUTLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641833 HUDSON AQUAPAK 301 SW,340 ML,INTL HUMIDIFIER BTT TELEFLEX MEDICAL 432147

    Patients

    Seq Age Sex Outcome Treatment
    1