BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23783376 · Received December 11, 2025

    Report

    Report Number
    1710034-2025-01938
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 8, 2025
    Report Date
    December 17, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825448
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    CUSTOMER INDICATES THAT TWO LOTS WERE USED FOR THE PATIENT AND THE LOT RELATED TO THIS REPORT IS NOT KNOWN. BATCH#: 5171710, MFR: 2025-06-20, EXP: 2028-05-31, BATCH#: 5174502, MFR: 2025-06-25, EXP: 2028-05-31.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    BD INSYTE AUTOGUARD BC 18GA X 1.16 IN IV (LOT: 5171710) NEEDLE NOT RETRACTING AT ALL. WE HAVE HAD SEVERAL SIMILAR INCIDENTS WITH THIS PRODUCT WITH VARIOUS LOTS. ALL SUBMITTED TO BD PRODUCT COMPLAINTS AS WELL. TWO RESULTED IN NEEDLESTICKS. REFERENCE REPORT#: MW5178095. AN EVENT ON 11/8 WHERE THE NURSE IS UNSURE WHICH LOT BECAUSE THEY HAD OPENED TWO IV CATHETERS FOR A CRITICAL PATIENT AND THE LOTS OF THE PACKAGES WERE 5171710 AND 5174502 (ONE OF THOSE DID NOT RETRACT WHEN THE BUTTON WAS PRESSED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2605646 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown