BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 5606469 · Received April 25, 2016

    Report

    Report Number
    9610847-2016-00011
    Event Type
    Injury
    Date Received
    April 25, 2016
    Date of Event
    April 11, 2016
    Report Date
    May 25, 2016
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    K923702
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: FOUR UNUSED/UNOPENED REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE UNITS REVEALED NO DAMAGE OR FOREIGN MATTER IN THE CANNULA TIP OR CATHETER THAT COULD CAUSE THE REPORTED DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5210764. ADDITIONALLY, NO ISSUES WERE FOUND IN THE DEVICE STERILIZATION REVIEW. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE CONFIRMED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PLACING A BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTO A PATIENT FOR A SUBCUTANEOUS INFUSION, THE PATIENT DEVELOPED AN AREA ON HIS/HER FLANK AND BACK THAT WAS RED AND HOT. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND HIS/HER HOSPITALIZATION WAS EXTENDED BY ONE WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259953 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5210764

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R