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: 9355474 · Received November 21, 2019

    Report

    Report Number
    9610847-2019-00693
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 3, 2019
    Report Date
    December 27, 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: 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 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. ADDITIONALLY, LEAKAGE TESTING WAS CONDUCTED ON THE RETURNED DEVICE; THE RESULTS FORM THIS TEST WERE ABLE TO IDENTIFY A SMALL TEAR IN THE CATHETER TUBING. THE SMALL WOUND IN THE TUBING IS INDICATIVE OF A NEEDLE PUNCTURE MARK; A REVIEW OF THE MANUFACTURING LINE WAS CONDUCTED TO IDENTIFY ANY POTENTIAL AREAS OF CONCERN THAT MAY EXIST WITHIN THE MANUFACTURING PROCESS, BUT OUR ENGINEERS WERE UNABLE TO ASSOCIATE THE ROOT CAUSE FOR THIS DAMAGE WITH ANY PORTION OF THE MANUFACTURING PROCESS. CURRENTLY, BD ENGINEERS SPECULATE THAT IT IS POSSIBLE UNDER THE RIGHT CONDITIONS FOR THE CATHETER TO BECOME PIERCED BY THE CANNULA WHEN THE DEVICE IS BEING REMOVED FROM A PARTIALLY OPENED PACKAGING UNIT.

    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 LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT BLOOD LEAKAGE AT CATHETER.

    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 LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT BLOOD LEAKAGE AT CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154065 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