BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 8330590 · Received February 12, 2019

    Report

    Report Number
    9610847-2019-00148
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Date of Event
    November 29, 2018
    Report Date
    March 11, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833130
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 7143717. 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THEY DID NOT DISPLAY THE FAILURE MODE CLEARLY ENOUGH TO IDENTIFY THE ROOT CAUSE. UNFORTUNATELY, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW. BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODES ACCORDING EVALUATED PHOTOS. CUSTOMER REPORTED REACTION AND LEAKAGE ISSUES; NEVERTHELESS, NO SAMPLE WAS RECEIVED FOR EVALUATION. AFTER ANALYZE BOTH PHOTOS BY THE ENGINEERING TEAM, WE CANNOT CONFIRM OR ASSOCIATE THE REPORTED DEFECTS TO MANUFACTURED PROCESS DUE TO 2 PHOTOS ONLY SHOWED LUMP ON THE SKIN. UNFORTUNATELY, WE COULD NOT BE IDENTIFIED THE ROOT CAUSE DUE TO THE UNIT DESCRIBED IN THE PRODUCT INCIDENT REPORT WAS NOT RETURNED FOR EVALUATION AND TESTING, WHICH IS ESSENTIAL TO PERFORM A BETTER INVESTIGATION. WE COULD NOT FOUND THE ROOT CAUSE OF THESE ISSUES. CERTIFICATE OF STERILITY MET WITH ACCEPTANCE CRITERIA.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM THERE WAS AN ISSUE WITH A LUMP THAT FORMED ON THE SKIN AFTER REMOVAL OF CATHETER. NO DISCOMFORT AND COULDN'T BE DEFINED AS ANYTHING OTHER THAN A NODULE.

    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 WITH THE USE OF THE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM THERE WAS AN ISSUE WITH A LUMP THAT FORMED ON THE SKIN AFTER REMOVAL OF CATHETER. NO DISCOMFORT AND COULDN'T BE DEFINED AS ANYTHING OTHER THAN A NODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127043 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7143717 30382903833130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other