BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 9130387 · Received September 27, 2019

    Report

    Report Number
    9610847-2019-00589
    Event Type
    Injury
    Date Received
    September 27, 2019
    Date of Event
    August 24, 2019
    Report Date
    September 30, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A LOT NUMBER COULD NOT BE CONNECTED TO THE DEVICE IDENTIFIED IN THE COMPLAINT, SO BD INVESTIGATORS COULD NOT CONDUCT A DEVICE HISTORY REVIEW FOR THIS EVENT. ADDITIONALLY, A SAMPLE WAS NOT SUBMITTED FOR EVALUATION AND TESTING, PREVENTING BD ENGINEERS FROM CONDUCTING A FULL INVESTIGATION AND DETERMINING A ROOT CAUSE OF THE FAILURE MODE IDENTIFIED IN YOUR DESCRIPTION OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INFECTION OCCURRED WITH A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MV 19-0685 : DERMOHYPODERMATITIS THAT OCCURRED FOLLOWING THE INFECTION OF A SUBCUTANEOUS INFUSION (REHYDRATION). THE DEVICE HAD TO BE REMOVED AND A NEW SET UP WAS LAID." DEVICES HAVE BEEN DISCARDED. A TREATMENT WITH VANCOMYCINE WAS DONE."

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 INFECTION OCCURRED WITH A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MV 19-0685 : DERMOHYPODERMATITIS THAT OCCURRED FOLLOWING THE INFECTION OF A SUBCUTANEOUS INFUSION (REHYDRATION). THE DEVICE HAD TO BE REMOVED AND A NEW SET UP WAS LAID.". DEVICES HAVE BEEN DISCARDED. A TREATMENT WITH VANCOMYCINE WAS DONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925584 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention