BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 18233774 · Received November 29, 2023

    Report

    Report Number
    1710034-2023-01353
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    September 12, 2023
    Report Date
    January 21, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814121
    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

    E1: (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

    INVESTIGATION RESULTS: THE COMPLAINT THAT THE NEEDLE WAS GETTING STUCK COULD NOT BE CONFIRMED FROM THE FIVE REPRESENTATIVE 22G INSYTE AUTOGUARD UNITS, WHICH WERE RECEIVED IN SEALED PACKAGING FROM LOT #3030482. A FUNCTIONAL TEST OF THE RETURNED UNITS REVEALED THAT EACH NEEDLE FULLY RETRACTED. NO DEFECTS ASSOCIATED WITH THE MANUFACTURING PROCESS WERE IDENTIFIED ON THE RETURNED SAMPLES. ALTHOUGH THE REPRESENTATIVE SAMPLES AND MANUFACTURING RECORDS DO NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A TREND WAS IDENTIFIED FOR NEEDLE RETRACTION FAILURE COMPLAINTS AND CORRECTIVE ACTIONS WILL CONTINUE TO BE MONITORED FOR EFFECTIVENESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. INVESTIGATION CONCLUSION(S): THE DEFECT OF FAILURE TO RETRACT WAS NOT CONFIRMED. PROBABLE ROOT CAUSE CONCLUSION(S): CANNOT BE DETERMINED IN THE ABSENCE OF A CONFIRMED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD HAD RETRACTION PROBLEMS. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: THE NEEDLE IS GETTING STUCK.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: WHEN THE BUTTON TO RETRACT THE NEEDLE WAS PUSHED THE NEEDLE DID NOT RETRACT AND THE NEEDLE CAUGHT THE TUBING WHEN PULLING IT OUT MANUALLY MAKING IT NECESSARY TO REPEAT THE IV INSERTION: NOTED DURING INSERTION AND AFTERWARDS WHEN CHECKING OTHER NEEDLES; THIS OCCURRED FOR 2 SEPARATE NURSES AND INVOLVED 3-5 PATIENTS; NO ADVERSE EVENTS OR SERIOUS INJURIES; IV LINE WAS INSERTED USING A NEW BOX; PATIENTS REQUIRED ADDITIONAL VENIPUNCTURES TO RE INSERT ADDITIONAL IV LINES. IT DID SLIGHTLY DELAY TREATMENT START TIMES. IV INSERTION; NO MEDICATION USED, IV LINE PRIMED WITH SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1924552 BD INSYTE AUTOGUARD INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3030482 00382903814121

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown