BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22G X 0.75 IN. BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM

    MDR report key: 6966888 · Received October 20, 2017

    Report

    Report Number
    9610847-2017-00122
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 27, 2017
    Report Date
    October 4, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903833238
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY/CONCLUSION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS BASED ON THE ABOVE A CAPA IS NOT REQUIRED AT THIS TIME. DHR REVIEW: A DHR WAS PERFORMED AND THIS IS THE FIRST COMPLAINT REPORTED WITH THE LOT NUMBER 7083683, FOR SAF T INTIMA. DHR FOR LOT NUMBER 7083683 WAS REVIEWED AND NO QNS OR OTHER EVENTS WERE RELATED TO THE COMPLAINT STATED BY THE CUSTOMER. MATERIAL (B)(4) WITH LOT NUMBER 7083683 WAS MANUFACTURED ON APRIL 18, 2017. ACCORDING TO SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED. DURING THIS LOT NUMBER (B)(4) SAMPLES WERE ACTIVATED BY QA TECH TO PERFORM 3 TEST OF PULL FORCE. - STYLET/CANNULA REMOVAL FORCE THROUGH INSERTER WINGS - STYLET/CANNULA REMOVAL FORCE THROUGH THE PRN COMPONENT - OUTER SAFETY SHEATH DISCONNECTION FORCE FROM PRN COMPONENT. NO VALUES OUT OF SPECIFICATION OR PROBLEMS DURING ACTIVATION OR EXPOSED CANNULA WERE FOUND. DURING DHR REVIEW THE QA TECH TAKES (B)(4) SAMPLES TO VISUAL INSPECTION BY (STYLET BENT), NO DEFECTS WERE FOUND IN FINAL ASSEMBLY. DURING DHR REVIEW THE QA TECH TAKES (B)(4) SAMPLES TO VISUAL INSPECTION BY (STYLET BENT). ADDITIONALLY, ALL FUNCTIONAL TEST MEETS SPECIFICATION CRITERIA REQUESTED DURING MANUFACTURING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A 22G X 0.75 IN. BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM A SEVERE BEND WAS DISCOVERED IN THE WIRE STYLET CAUSING THE SAFETY ACTIVATION MECHANISM TO FAIL. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743600 22G X 0.75 IN. BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7083683 00382903833238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other