BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 16433366 · Received February 23, 2023

    Report

    Report Number
    9610847-2023-00035
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    January 23, 2023
    Report Date
    March 21, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903833368
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE 2 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF NEEDLE DEFECT (OTHER) WAS NOT CONFIRMED UPON INSPECTION OF THE PHOTOS. BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. DHR WAS REVIEWED AND NO QNS OR OTHER EVENTS WERE FOUND RELATED TO THE COMPLAINT STATED BY THE CUSTOMER. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM SAFETY MECHANISM FAILED AND A NEEDLE STICK INJURY OCCURRED AS A RESULT. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SAFT-INTIMA DEVICE FAILED AND A NEEDLESTICK INJURY OCCURRED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM SAFETY MECHANISM FAILED AND A NEEDLE STICK INJURY OCCURRED AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SAFT-INTIMA DEVICE FAILED AND A NEEDLESTICK INJURY OCCURRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859319 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 1210981 00382903833368

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention