BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM

    MDR report key: 8174970 · Received December 18, 2018

    Report

    Report Number
    9610847-2018-00435
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    November 15, 2018
    Report Date
    January 23, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 7143693. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF A DAMAGED TUBING OCCURRING IN THIS BATCH SAF-T-INTIMA. 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, OUR QUALITY ENGINEERS REVIEWED THE SAMPLE SUBMITTED. THEY WERE ABLE TO VERIFY THAT THE TUBING HAD SUFFERED A PARTIAL CUT, BUT ALL ATTEMPTS TO REPLICATE THE EVENT USING MULTIPLE APPLICATIONS OF THE SLIDE CLAMP WERE UNSUCCESSFUL. UNFORTUNATELY WITHOUT A SUCCESSFUL DUPLICATION OF THE EVENT, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE FINALIZED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM LEAKED FROM THE EXTENSION TUBING AT THE CLAMP.

    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¿ INTEGRATED SAFETY CATHETER SYSTEM LEAKED FROM THE EXTENSION TUBING AT THE CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016901 BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7143693 30382903833123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other