BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 16427799 · Received February 23, 2023

    Report

    Report Number
    9610847-2023-00031
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    January 12, 2023
    Report Date
    March 6, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903833283
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SINCE NO PHOTOS OR SAMPLES DISPLAYING THE REPORTED CONDITION OF INFECTION WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2010635 NO DEFECTS WERE FOUND.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM AN INFECTION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ZONE INFLAMMATION LEFT SHOULDER EVACUATION PUS+++ COMPRESS WITH BETADINE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM AN INFECTION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ZONE INFLAMMATION LEFT SHOULDER EVACUATION PUS+++ COMPRESS WITH BETADINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449339 BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2010635 00382903833283

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention