BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD WINGED

    MDR report key: 20340243 · Received September 30, 2024

    Report

    Report Number
    1710034-2024-01077
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 4, 2024
    Report Date
    November 1, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903815234
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE UPDATED TO 04SEP24 IN B TAB. INVESTIGATION RESULTS: THE COMPLAINT OF HAIR IN THE PACKAGE WAS CONFIRMED AND THE UNINTENDED MATERIAL WAS LIKELY INTRODUCED DURING PACKAGING. ONE PHOTOGRAPH AND TWO 20G INSYTE AUTOGUARD UNITS WERE PROVIDED FOR INVESTIGATION. HAIR WAS OBSERVED ACROSS THE TWO-UNIT PACKAGES. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    EVENT DATE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED HAS FOREIGN MATTER IN PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSES FOUND A HAIR INSIDE TWO STERILE PACKAGES FROM LOT# 4123605 REF # 381523. WE HAVE BEEN UNFORTUNATELY USING THIS LOT BEFORE THE TAMPERED PACKAGE WAS FOUND. PLEASE REIMBURSE FOR THE LOT NUMBER AND ISSUE OUT A NEW BOX ASAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40690 BD INSYTE AUTOGUARD WINGED PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4123605 00382903815234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown