BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON PEDIATRIC BREATHING CIRCUIT, 30"

    MDR report key: 3994037 · Received July 24, 2014

    Report

    Report Number
    3004365956-2014-00284
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 28, 2014
    Report Date
    July 10, 2014
    Manufacturer
    TELEFLEX
    Product Code
    OFP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD OF BATCH NUMBER 02H1301128 WAS REVIEWED AND THERE WERE NO ISSUES OR DISCREPANCIES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. NO NON-CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION. THE DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. THE SAMPLE WAS RECEIVED, HOWEVER, THE INVESTIGATION RESULTS WERE NOT COMPLETE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT CIRCUITS WERE PULLED FROM STOCK AND WERE FOUND TO BE CRACKED AT THE END. THE ISSUE WAS DETECTED PRIOR TO PT USE DURING AN INSPECTION. QUANTITY = (B)(4) PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434779 HUDSON PEDIATRIC BREATHING CIRCUIT, 30" ANESTHESIA BREATHING CIRCUIT OFP TELEFLEX 02H1301128

    Patients

    Seq Age Sex Outcome Treatment
    1