BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6190113 · Received December 20, 2016

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    Report

    Report Number
    9610847-2016-00053
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    December 1, 2016
    Report Date
    January 27, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ON 01/19/2017, 199 UNUSED REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION OF ALL SAMPLES REVEALED NO DAMAGE TO ANY OF THE DEVICES. A PULL FORCE/SIMULATED USE TEST WAS CONDUCTED ON ALL SAMPLES AND THERE WERE NO FAILURES WITH SAFETY MECHANISM ACTIVATION NOR WERE THERE ANY EXPOSED NEEDLES AFTER ACTIVATION. AS PREVIOUSLY REPORTED, THERE WERE NO IRREGULARITIES FOUND IN THE DEVICE HISTORY RECORD OR MANUFACTURING RECORD REVIEWS. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6208763. A MANUFACTURING REVIEW INDICATED THAT THE REPORTED DEFECT IS NOT RELATED TO THE ASSEMBLY PROCESS. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY MECHANISM OF A 22 G X 0.75 IN. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM DID NOT ENGAGE LEAVING NEEDLE EXPOSED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840084 22 G X 0.75 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6208763

    Patients

    Seq Age Sex Outcome Treatment
    1 Other