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: 9105644 · Received September 23, 2019

    Report

    Report Number
    9610847-2019-00581
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Date of Event
    August 15, 2019
    Report Date
    October 3, 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: 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. 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. BASED ON THE INVESTIGATION CONCLUSION THE CONDITION REPORTED BY THE CUSTOMER WAS NOT CONFIRMED. NO SAMPLES OF PHOTOS WERE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 24 G X 0.75 IN. EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT FLOC FOREIGN MATTER ON THE NEEDLE TIP AFTER UNWRAPPED THE PACKAGE.

    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 THAT THE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 24 G X 0.75 IN. EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT FLOC FOREIGN MATTER ON THE NEEDLE TIP AFTER UNWRAPPED THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901732 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