BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURFLO I.V. CATHETER

    MDR report key: 3180389 · Received June 20, 2013

    Report

    Report Number
    1118880-2013-00025
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    FOZ
    PMA / PMN Number
    K891087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT ASSOCIATED WITH A HUMAN PATIENT. THE INVOLVED DEVICE WAS NOT RETURNED BY THE USER FACILITY, WHICH LIMITS THE INVESTIGATION. THE INVESTIGATION WAS BASED UPON EVALUATION OF USER FACILITY INFORMATION AND RESERVE SAMPLES. VISUAL INSPECTION OF RESERVE SAMPLES CONFIRMED THERE WERE NO ABNORMALITIES OR DEFECTS. FUNCTIONAL TESTING OF RESERVE SAMPLES CONFIRMED THAT PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THE REPORTED LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. THERE IS NO INDICATION THAT THERE WAS ANY RELATION TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED, THE EVENT DESCRIPTION IS MOST CONSISTENT WITH THE CATHETER TUBING HAVING BEEN DAMAGED AND SEVERED BY CONTACT WITH A SHARP OBJECT, SUCH AS SCISSORS, DURING THE REMOVAL PROCESS. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR TRACKING, TRENDING, AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY (A VETERINARY HOSPITAL) REPORTED THAT THE DISTAL PORTION OF THE IV CATHETER TUBING WAS FOUND TO HAVE BECOME DETACHED FOLLOWING A PROCEDURE ON A GREYHOUND CANINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CONTACT AT THE ANIMAL HOSPITAL: (1) UPON REMOVAL OF THE BANDAGE, A PORTION OF THE DISTAL END OF THE IV CATHETER WAS NOTED TO HAVE BEEN DETACHED FROM THE REMAINDER OF THE TUBING; (2) THE DETACHED PORTION WAS ABLE TO BE SUCCESSFULLY REMOVED; AND (3) THE ANIMAL IS REPORTED TO BE ¿FINE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281597 SURFLO I.V. CATHETER INTRAVASCULAR CATHETER FOZ TERUMO MEDICAL CORPORATION NA NN1626

    Patients

    Seq Age Sex Outcome Treatment
    1