BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 7492919 · Received May 7, 2018

    Report

    Report Number
    9610847-2018-00124
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    April 19, 2018
    Report Date
    June 15, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903833221
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A SAMPLE WAS RECEIVED FOR THE PURPOSE OF OUR INVESTIGATION. THE INVESTIGATORS WERE ABLE TO OBSERVE THE REPORTED FAILURE MODE IN THE SAMPLE PROVIDED. THE DEVICE HISTORY REPORT FOR LOT NUMBER 6243979 WAS REVIEWED, NO RELATED ABNORMALITIES WERE FOUND. MATERIAL NUMBER 383322 FOR LOT 6243979 WAS MANUFACTURED ON 09/21/2016. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED. ALL SAMPLES WERE REVIEWED FOR VISUAL AND FUNCTIONAL CHARACTERISTIC, INVESTIGATORS WERE UNABLE TO IDENTIFY ANY ABNORMALITIES AS A RESULT OF THEIR INSPECTION. THE ROOT CAUSE FOR THIS FAILURE MODE COULD NOT BE DETERMINED, HOWEVER THE CLAMP THAT IS CITED IN THE COMPLAINT IS NOT ACTIVATED WHEN SHIPPED. THIS SUGGESTS THAT THE DAMAGE RESULTED FROM USE OF THE DEVICE AND DOES NOT PLAY A ROLE IN THE MANUFACTURING PROCESS. NO CORRECTIVE ACTION REQUIRED AT THE FAILURE. THE MANUFACTURING PROCESS WAS REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE NURSE THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM LEAKED FROM THE E-TUBING NEAR THE CLAMP DURING INFUSION. NO BLOOD EXPOSURE TO MUCOUS MEMBRANES. NO SOLUTION EXPOSURE TO BARE SKIN. NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335884 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRACASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6302608 00382903833221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other