BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15965512 · Received December 12, 2022

    Report

    Report Number
    9610847-2022-00467
    Event Type
    Injury
    Date Received
    December 12, 2022
    Date of Event
    November 21, 2022
    Report Date
    December 15, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SINCE NO PHOTOS OR SAMPLES DISPLAYING THE REPORTED CONDITION OF IRRITATION / INFLAMMATION WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. DHR WAS REVIEWED AND NO QNS OR OTHER EVENTS WERE FOUND RELATED TO THE COMPLAINT STATED BY THE CUSTOMER. ACCORDING TO SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER FLUID INFUSION WITH BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM, CELLULITIS FORMED AND PATIENT WAS TREATED WITH ANTIBIOTIC TREATMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CELLULITIS FORMATION AFTER FLUID INFUSION WITH THE PRODUCT. ACCORDING TO THE STUFF, THE PATIENT TREATED WITH ANTIBIOTIC TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER FLUID INFUSION WITH BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM, CELLULITIS FORMED AND PATIENT WAS TREATED WITH ANTIBIOTIC TREATMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CELLULITIS FORMATION AFTER FLUID INFUSION WITH THE PRODUCT. ACCORDING TO THE STUFF, THE PATIENT TREATED WITH ANTIBIOTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407721 BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2005900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention