BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON 22MM DUAL HTD CIRC KIT

    MDR report key: 5448577 · Received February 19, 2016

    Report

    Report Number
    3004365956-2016-00128
    Event Type
    Malfunction
    Date Received
    February 19, 2016
    Date of Event
    February 4, 2016
    Report Date
    February 8, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). CONCLUSION(S) - A CONCLUSION CODE COULD NOT BE CHOSEN. THE COMPLAINT WAS CONFIRMED, VIA VISUAL/PHOTO INSPECTION, BUT THE ROOT CAUSE IS UNKNOWN. ONE PICTURE OF PRODUCT P/N 870-35KIT (22MM DUAL HTD CIRC KIT) WAS RECEIVED FOR ANALYSIS. IT WAS VISUALLY INSPECTED, FINDING THE CONNECTION OF THE ELBOW P/N TFX-000149 WITH THE CORRUGATED TUBING P/N 161050-03 DETACHED. A DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. NO CORRECTIVE ACTION CAN BE ESTABLISHED SINCE THE SAMPLE IS NOT AVAILABLE TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE VISUAL INSPECTION OF THE RECEIVED PICTURE, BECAUSE OF CONNECTION DETACHMENT OF THE ELBOW P/N TFX-000149 WITH THE CORRUGATED TUBING P/N 161050-03 DETACHED. ALTHOUGH THE COMPLAINT IS CONFIRMED BASED ON THE PICTURE PROVIDED, THERE IS NO SUFFICIENT EVIDENCE TO ASSURE THIS ISSUE WAS ORIGINATED DURING THE MANUFACTURING PROCESS. OTHER REMARKS: THE ROOT CAUSE FOR THE CONDITION REPORTED COULD NOT BE IDENTIFIED. TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THIS COMPLAINT. HOWEVER, 29 SAMPLES OF CURRENT PRODUCTION P/N 870-35KIT (22MM DUAL HTD CIRC KIT) WERE REVIEWED AND INSPECTED PERFORMING A SUBJECTIVE PULL TEST TO THESE CONNECTIONS AND NO ISSUES WERE FOUND THAT CAN LEAD TO THE CONDITION REPORTED BY THE CUSTOMER. IF THE DEVICE DEFECTIVE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE CIRCUIT CAME UNGLUED WHERE THE EXPIRATORY CORRUGATED TUBING CONNECTS TO THE HARD PLASTIC PIECE. THE ALLEGED ISSUE WAS OBSERVED AFTER A VENT DISCONNECT ALARM WAS TRIGGERED (DURING CHANGE OUT OF EXPIRATORY FILTER). THE CIRCUIT WAS IN USE FOR APPROXIMATELY 27 DAYS. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103493 HUDSON 22MM DUAL HTD CIRC KIT RESPIRATORY GAS HUMIDIFIER BTT TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1