BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD

    MDR report key: 17485198 · Received August 8, 2023

    Report

    Report Number
    1710034-2023-00891
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 25, 2023
    Report Date
    September 15, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH WHICH DISPLAYED A 20GX1.00IN INSYTE AUTOGUARD FROM LOT NUMBER 3033950. THE CATHETER WAS FULL OF BLOOD RESIDUE AND THE NEEDLE WAS PROTRUDING THROUGH THE SIDE OF THE CATHETER TUBING. DUE TO THE EVIDENCE OF USE, THE DAMAGE LIKELY OCCURRED DURING THE INSERTION PROCESS. THE IFU INDICATES TO NOT REINSERT THE NEEDLE INTO THE CATHETER DURING THE INSERTION PROCESS AS DAMAGE MAY OCCUR. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    E1. ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, NJ WAS USED AS A PLACE HOLDER. H3. 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 5 OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL EXPERIENCED NEEDLE THROUGH CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE HAS PUNCTURED THROUGH THE CATHETER, 5 OCCURRENCES AS REPORTED BY CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL EXPERIENCED NEEDLE THROUGH CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE HAS PUNCTURED THROUGH THE CATHETER, 5 OCCURRENCES AS REPORTED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688349 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3033950 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown