BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFETY WINGED INFUSION SET

    MDR report key: 6833478 · Received August 31, 2017

    Report

    Report Number
    3004102031-2017-00007
    Event Type
    Injury
    Date Received
    August 31, 2017
    Date of Event
    August 3, 2017
    Report Date
    August 31, 2017
    Manufacturer
    TERUMO MEDICAL PRODUCTS HANGZHOU
    Product Code
    FPA
    PMA / PMN Number
    K031266
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - THE UDI NUMBER FOR THIS PRODUCT CODE IS NOT REQUIRED. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED ON THE USER FACILITY INFORMATION AND PHOTOS PROVIDED BY THE USER FACILITY. ON AUG.10,2017, WE RECEIVED PICTURES OF ACTUAL SAMPLE. THE PICTURES SHOWED THE SAFETY DEVICE COULD BE SUCCESSFULLY ACTIVATED AND THE NEEDLE COULD BE LOCKED INTO THE SAFETY COVER AND THE TEETH WITHIN THE SAFETY COVER WERE INTACT WITHOUT DAMAGE. NO ABNORMITIES WERE OBSERVED ON THE ACTUAL DEVICE. RELATED TESTS, SUCH AS VISUAL INSPECTION, THE ANGLE OF THE SAFETY SHIELD, ACTIVATION OF SAFETY SHIELD, BREAKAGE RESISTANCE TEST AFTER ACTIVATION OF SAFETY UNIT AND SIMULATION TEST TO THE RETAINED SAMPLES SHOW NO ABNORMITIES. A REVIEW OF THE MANUFACTURE RECORD AND RELEASE INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION REVEALED NO RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND ONE PREVIOUS REPORT OF THIS NATURE WITHIN THE LAST TWO YEARS. SEE MDR NUMBER 3004102031-2016-00003. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. WITH NO RETURN OF THE ACTUAL DEVICE THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD. (MANUFACTURER) REGISTRATION NO. 3004102031. EXEMPTION NUMBER E2015024. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A NEEDLE STICK WITH THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE NURSE WITHDREW THE NEEDLE AFTER INFUSION AND ACTIVATED THE SAFETY DEVICE TO LOCKED IT INTO THE SHIELD; THE NURSE PLACED THE INFUSION SET ON THE I.V. DRIP STAND TO STANCH THE BLEEDING; AFTER STANCHING THE BLEEDING THE NURSE INCURRED A NEEDLE STICK; THE NURSE REPORTED THE "CLICK" SOUND FOR ACTIVATING THE SAFETY COVER WAS FELT; THE HEAD NURSE REPORTED THE SAFETY COVER WAS ACTIVATED UPON RECEIVING THE SAMPLE; AND THE NURSE RECEIVED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614600 SAFETY WINGED INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA TERUMO MEDICAL PRODUCTS HANGZHOU N/A 170418A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R