BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 24 G X 0.75 IN.

    MDR report key: 8971752 · Received September 6, 2019

    Report

    Report Number
    9610847-2019-00555
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    July 30, 2019
    Report Date
    September 19, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833123
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8212735. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. PFMEA¿S 4797 AND P-EURA RM5942 WAS REVIEWED AND PROCESS CONTROLS ARE VERY LIKELY TO DETECT FAILURE MODES AND PREVENT FAILURES END USERS. THE REPORTED DEFECT IS RELATED WITH A INCORRECT USE OF THE DEVICE THERE ARE 2 FORM TO CAUSE EXPOSED NEEDLE: STYLET PULLER AND INNER OUTER ARE ACTIVATED TOGETHER FROM THE BOTTOM PART INSTEAD OF PULLING FROM THE GRIPS MARKED ON THE STYLET PULLER. THE PRN ADAPTER IS UNSCREWED FROM THE LUER ADAPTER AND THEN THE STYLET IS PULLED FROM THE PRN INSTEAD OF THE STYLET PULLER. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 24 G X 0.75 IN. HAS BEEN FOUND EXPERIENCING SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT SAFETY SHIELD ACTIVATION FAILURE, RESULT IN NEEDLE TIP EXPOSED AFTER COMPLETE PENETRATION AND REMOVE THE NEEDLE CORE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 24 G X 0.75 IN. HAS BEEN FOUND EXPERIENCING SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT SAFETY SHIELD ACTIVATION FAILURE, RESULT IN NEEDLE TIP EXPOSED AFTER COMPLETE PENETRATION AND REMOVE THE NEEDLE CORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764700 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 24 G X 0.75 IN. INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8212735 30382903833123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other