BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24 G X 0.75 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 6106387 · Received November 16, 2016

    Report

    Report Number
    9610847-2016-00042
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 25, 2016
    Report Date
    November 30, 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

    (B)(4). DEVICE EVALUATION: A SAMPLE HAS BEEN RETURNED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - FOUR UNUSED REPRESENTATIVE SAMPLES WERE RECEIVED IN SEALED PACKAGES. THE SAMPLES WERE VISUALLY INSPECTED AND NO FOREIGN MATTER OR CONTAMINATION WAS FOUND IN THE CANNULA TIP OR CATHETER. THE DEVICE HISTORY RECORD FOR LOT NUMBER 6124986 WAS REVIEWED AND NO QNS OR OTHER EVENTS WERE RELATED TO THE COMPLAINT STATED BY THE CUSTOMER. MATERIAL (B)(4) WITH LOT NUMBER 6124986 WAS MANUFACTURED ON MAY 10, 2016. ACCORDING TO SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT PROBLEMS. DURING THIS ASSEMBLY NO DEFECTS OR CONTAMINATION WERE FOUND IN FINAL ASSEMBLY AND PACKAGING THAT COULD AFFECT WITH THE DEFECT REPORTED. THE CERTIFICATE OF STERILIZATION DOES NOT SHOW ANY PROBLEMS THAT COULD CONTRIBUTE TO THE DEFECT REPORTED. CONCLUSION - BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RECEIVING A SUBCUTANEOUS INFUSION OF GLUCOSE 5%, DEXTROSE 2.5% AND NACL TROUGH THE SUSPECT DEVICE. AN ABSCESS WAS NOTED ON THE 3RD DAY. THE ABSCESS WAS DRAINED AT THE PATIENT BEDSIDE WITH A SCALPEL AND ANTIBIOTICS WERE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759036 24 G X 0.75 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTEGRATED SAFETY IV CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6124986

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention