BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON TUBING, OXYGEN SUPPLY, 7

    MDR report key: 3994409 · Received July 23, 2014

    Report

    Report Number
    3004365956-2014-00296
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 10, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT OR A PICTURE OF THE DEFECT WAS NOT PROVIDED. A DHR (DEVICE HISTORY RECORD) REVIEW COULD NOT BE CONDUCTED SINCE REPORTED LOT NUMBER "43511311" IS NOT A VALID LOT NUMBER FOR TELEFLEX AT THE (B)(4). ALL LOT NUMBERS FROM TELEFLEX AT THE(B)(4) CONSIST OF TEN CHARACTERS. A CORRECTIVE ACTION CANNOT BE APPLIED SINCE IT IS NOT POSSIBLE TO IDENTIFY THE DEFECT REPORTED AND TO INVESTIGATE ITS ROOT CAUSE, IN ORDER TO PERFORM A PROPER INVESTIGATION IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THE INCIDENT. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED SOLELY ON THE INFO PROVIDED. IN ORDER TO PERFORM A PROPER INVESTIGATION IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THE INCIDENT; HOWEVER, CURRENT PRODUCTION WAS VERIFIED TO IDENTIFY ANY ISSUE THAT CAN LEAD TO THE REPORTED DEFECT AND NO ISSUES WERE FOUND. IF THE DEVICE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVAL RESULTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE MASK COULD NOT BE DISCONNECTED FROM THE CONNECTOR, AND THUS THE CONNECTOR COMES AWAY FROM THE TUBING. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432324 HUDSON TUBING, OXYGEN SUPPLY, 7 OXYGEN TUBING BYG TELEFLEX 43511311

    Patients

    Seq Age Sex Outcome Treatment
    1