BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 18234455 · Received November 29, 2023

    Report

    Report Number
    1710034-2023-01357
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 3, 2023
    Report Date
    January 8, 2024
    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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1: INITIAL REPORTER ADDRESS: (B)(6). H3. 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

    CORRECTION: AN ADDITIONAL LOT NUMBER WAS PROVIDED IN THIS COMPLAINT FOR MATERIAL NUMBER (B)(4). LOT # 3178595 MNF DATE2023-06-29/EXP DATE 2026-06-30. DEVICE EVALUATION: THE COMPLAINT OF A LEAK COULD NOT BE CONFIRMED FROM THE 15 REPRESENTATIVE 20G INSYTE AUTOGUARD UNITS THAT WERE RECEIVED IN SEALED PACKAGING FROM LOT #3192270. A FUNCTIONAL TEST OF THE RETURNED SAMPLES REVEALED THAT THE LEAK COULD NOT BE CONFIRMED. A REVIEW OF THE INSPECTION RECORDS AND QUALITY/MANUFACTURING CONTROLS FOR THE IMPLICATED LOT INDICATED NO ISSUES WITH THE MANUFACTURING PROCESS. THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: SOME ARE LEAKING, SOME GET JAMMED & DON'T RETRACT.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072610 BD INSYTE AUTOGUARD INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3192270 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown