BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 11821219 · Received May 13, 2021

    Report

    Report Number
    1710034-2021-00398
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 12, 2021
    Report Date
    June 7, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815235
    PMA / PMN Number
    K201075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE ONLY PARTIALLY RETRACTED, CAUSING A DIRTY NEEDLE STICK INJURY TO THE STAFF MEMBER'S LEG WHEN DROPPED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSE INITIATED IV ACCESS IN PATIENT, PUSHED BUTTON TO RETRACT THE NEEDLE PORTION OF PRODUCT, WOULD NOT RETRACT. MULTIPLE ATTEMPTS TO RETRACT CONTAMINATED NEEDLE, BUT WOULD NOT WORK. DROPPED NEEDLE, POKED STAFF MEMBER IN LEG."

    Additional Manufacturer Narrative · 1

    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 THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE ONLY PARTIALLY RETRACTED, CAUSING A DIRTY NEEDLE STICK INJURY TO THE STAFF MEMBER'S LEG WHEN DROPPED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSE INITIATED IV ACCESS IN PATIENT, PUSHED BUTTON TO RETRACT THE NEEDLE PORTION OF PRODUCT, WOULD NOT RETRACT. MULTIPLE ATTEMPTS TO RETRACT CONTAMINATED NEEDLE, BUT WOULD NOT WORK. DROPPED NEEDLE, POKED STAFF MEMBER IN LEG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716389 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381523 0342576 30382903815235

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention