BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 22 G X 0.75 IN.

    MDR report key: 8805355 · Received July 18, 2019

    Report

    Report Number
    9610847-2019-00474
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    May 15, 2019
    Report Date
    August 13, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833222
    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: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8212741. 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.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 22 G X 0.75 IN. EXPERIENCED NEEDLE DISENGAGEMENT DIFFICULT BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: NOTICED NEEDLE DISENGAGEMENT DIFFICULT DURING THE PREPARATION OF PENETRATION.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 22 G X 0.75 IN. EXPERIENCED NEEDLE DISENGAGEMENT DIFFICULT BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: NOTICED NEEDLE DISENGAGEMENT DIFFICULT DURING THE PREPARATION OF PENETRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599463 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 22 G X 0.75 IN. INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8212741 30382903833222

    Patients

    Seq Age Sex Outcome Treatment
    1 Other