BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD WINGED BL 22GA X 1.0IN

    MDR report key: 18789987 · Received February 27, 2024

    Report

    Report Number
    1710034-2024-00138
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    February 8, 2024
    Report Date
    March 12, 2025
    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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BECTON DICKINSON AND COMPANY'S (BD) MEDICATION DELIVERY SOLUTIONS (MDS) BUSINESS UNIT WILL DISCONTINUE MALFUNCTION MDR REPORTING FOR CERTAIN DEVICE FAILURES THAT HAVE NOT CAUSED OR CONTRIBUTED TO DEATHS OR SERIOUS INJURIES IN THE PAST TWO YEARS, AND WHERE THE LIKELIHOOD OF A DEATH OR SERIOUS INJURY AS A RESULT OF THESE MALFUNCTIONS IS REMOTE. THIS DECISION FOLLOWS FDA GUIDELINES (MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ISSUED NOV 8, 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON MAR 3, 2025. FDA HAS REVIEWED AND RESPONDED TO BD¿S NOTIFICATION (REFERENCE FDA DOCUMENT#: (B)(4) ON MARCH 7, 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP) AS DIR (B)(4). THIS SUPPLEMENTAL MDR IS BEING FILED TO DOCUMENT THAT THE BELOW DEVICE FAILURE WILL NO LONGER BE CONSIDERED A REPORTABLE MALFUNCTION MDR FOR THE PRODUCT FAMILY BELOW: PRODUCT FAMILY: INSYTE AUTOGUARD, DEVICE FAILURE: CONNECTOR LOOSE.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE OR BATCH NUMBER WERE PROVIDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED BL 22GA X 1.0IN EXPERIENCED DIFFICULTY WITH THE CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSERTED INTO VEIN WITH FLASHBACK HOWEVER WHEN ATTEMPTING TO CONNECT OF LUER OF PS 238338 = SET EXTENSION STRAIGHT 3.4ML 20IN INTRAVENOUS MALE LUER LOCK ADAPTER STANDARD BORE 2 LUER ACTIVATE VALVE RETRACT COLLAR STERILE CLEAR LINK LATEX FREE DEHP ALLEGIANCE CORP. BAXTER IV 2C8606 HUB OF 101761 DISTORTED NOT PERMITTING CONNECTION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657070 BD INSYTE AUTOGUARD WINGED BL 22GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903815234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown