BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,INT

    MDR report key: 6046788 · Received October 21, 2016

    Report

    Report Number
    1417411-2016-00132
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 19, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF THE DEVICE SAMPLE IS AVAILABLE FOR EVALUATION. A VISUAL, FUNCTIONAL, AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RECEIVED YET AT OUR FACILITY. A DHR REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER (0120) PROVIDED ON THE CUSTOMER COMPLIANT DOES NOT BELONG TO (B)(4) FACILITIES, THIS IS A INCORRECT LOT NUMBER. NO DEVICE SAMPLE AVAILABLE FROM THE CUSTOMER TO INVESTIGATE. TELEFLEX (B)(4) WILL CONTINUE TO MONITOR FEEDBACK FROM THE CUSTOMERS ON ISSUES RELATED TO THIS COMPLAINT DESCRIPTION. CUSTOMER COMPLAINT CANNOT BE CONFIRMED, BASED ONLY ON THE INFORMATION PROVIDED BY CUSTOMER. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4).-LOT NUMBER CORRECTED TO 237167. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON LOT NUMBER 237167 AND THERE WERE ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. A SAMPLE WAS RETURNED FOR EVALUATION (AQUAPAK, PRODUCT CODE 400301 ALONG WITH THE ADAPTOR, PRODUCT CODE 400040). IT WAS IN THE ORIGINAL PACKAGING AND IT WAS NOT OPENED. A VISUAL EXAM WAS PERFORMED ON THE RETURNED SAMPLE AND NO ISSUES WERE OBSERVED. NO DAMAGES WERE FOUND ON THE THREAD OF THE ADAPTOR. THE SAMPLE WAS PLACED ON THE OXYGEN FLOWMETER UNDER OXYGEN FLOW AT 15 L /MIN FOR 3 MINUTES AND NO OXYGEN LEAKAGE AND NO ISSUES CONCERNING THE FIXATION WERE FOUND OR DETECTED IN ANY PARTS OF THE DEVICE. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THERE WERE NO ISSUES FOUND WITH THE RETURNED DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES HAVING AN ISSUE WITH CONNECTION OF THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES HAVING AN ISSUE WITH CONNECTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699839 HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,INT HUMIDIFIER NEBULIZER KIT OGG TELEFLEX MEDICAL 237167

    Patients

    Seq Age Sex Outcome Treatment
    1