BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON OXYGEN SUPPLY TUBING, 7'

    MDR report key: 3181878 · Received June 17, 2013

    Report

    Report Number
    3004365956-2013-00196
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 30, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT HISTORY REVIEW WAS CONDUCTED ON THE CATALOG NUMBER IN QUESTION FROM 05/20/2012 TO 05/20/2013. NO COMPLAINTS WERE RECEIVED IN THIS RANGE WITH THE SAME ISSUE. CUSTOMER COMPLAINT IS CONFIRMED BASED ON THE PICTURE PROVIDED, HOWEVER CURRENT PRODUCTION WAS VERIFIED TO IDENTIFY ANY ISSUES THAT CAN LEAD TO THE REPORTED DEFECT AND NO ISSUES WERE FOUND. THIS IS CONSIDERED AS AN ISOLATED EVENT. NO OTHER ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE CUSTOMER ALLEGES THAT THE TUBE WAS OCCLUDED BY A PIECE OF FOREIGN MATERIAL. THE ISSUE WAS DETECTED PRIOR TO PT USE. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274084 HUDSON OXYGEN SUPPLY TUBING, 7' OXYGEN SUPPLY TUBING BZO TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1