BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR

    MDR report key: 5290587 · Received December 11, 2015

    Report

    Report Number
    1417411-2015-00181
    Event Type
    Malfunction
    Date Received
    December 11, 2015
    Date of Event
    December 1, 2015
    Report Date
    December 1, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TWO PICTURES OF THE PRODUCT CATALOG NUMBER (003-40; AQUAPAK 340 SW,340 ML W/040 ADAPTOR) WERE RECEIVED FOR ANALYSIS. THEY WERE VISUALLY INSPECTED AND NO 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. THE DEVICE RECORDS REVIEWED SHOWED NO RELATED FUNCTIONAL ISSUES ON THE MOLDED COMPONENT INVOLVED IN THIS COMPLAINT. 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. A CAPA FILE #40005320 (B)(4) TO THE CAPA INVESTIGATION, SO FAR, THE ROOT CAUSE FOR THE ISSUE WAS THE POSITIONING OF THE THREAD 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.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE AQUAPAK BOTTLE DROPPED TO THE GROUND DUE TO THE ADAPTOR/THREAD NOT HOLDING THE DEVICE IN PLACE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820371 HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR HUMIDIFIER NEBULIZER KIT OGG TELEFLEX MEDICAL 463147

    Patients

    Seq Age Sex Outcome Treatment
    1