BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 8704370 · Received June 17, 2019

    Report

    Report Number
    9610847-2019-00418
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 18, 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
    NURSE

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM THE CATHETER WAS BROKEN AT THE END PART AFTER PENETRATION. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE NURSE FOUND THAT THE CATHETER WAS BROKEN AT THE END PART AFTER PENETRATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8148626. 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. 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. INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. BASED ON INVESTIGATION RESULTS, THE ROOT CAUSE WAS NOT IDENTIFIED BECAUSE THE CUSTOMER DID NOT PROVIDE THE DEFECTIVE SAMPLE WHICH IS ESSENTIAL TO PERFORM A BETTER INVESTIGATION. ACCORDING WITH THE EVENT DESCRIPTION THIS DEFECT HAPPENED DURING ITS USE. UNFORTUNATELY WITHOUT DEFECTIVE SAMPLE OR PHOTO WE COULD NOT DETERMINATE IF DAMAGE IN THE CATHETER WAS CAUSED WITH THE NEEDLE DURING ITS USE OR AN INCORRECT ASSEMBLY. BASED ON DHR REVIEW FOR LOT REPORTED OF CATALOG 383312, ALL SAMPLES TAKEN FOR VISUAL AND FUNCTIONAL CHARACTERISTICS PROPERLY MET THE ACCEPTANCE CRITERIA. QUALITY RECORDS HAVE BEEN CONSULTED FOR TRACKING AND TRENDING PURPOSES AND NO ISSUES ARE DETECTED WHICH MEANS PRETTY LOW OCCURRENCE. ALWAYS REFER TO IFU FOR PRODUCT USAGE RECOMMENDATIONS. PROCESS FMEA 4797 AND P-EURA RM5942 WERE REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. ROOT CAUSE DESCRIPTION: BASED ON INVESTIGATION RESULTS TO DATE, ROOT CAUSE FOR MANUFACTURING PROCESS CANNOT BE DETERMINED. NO SAMPLE OR PHOTO WAS RECEIVED FOR EVALUATION RATIONALE: NO CORRECTIVE ACTION WAS PERFORMED SINCE THIS ISSUE COULD NOT BE CONFIRMED AS MANUFACTURING RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM THE CATHETER WAS BROKEN AT THE END PART AFTER PENETRATION. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE NURSE FOUND THAT THE CATHETER WAS BROKEN AT THE END PART AFTER PENETRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497178 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8148626 30382903833123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other