BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 17808049 · Received September 25, 2023

    Report

    Report Number
    1710034-2023-01097
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    September 14, 2023
    Report Date
    November 2, 2023
    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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE 20GA X 1.00IN. INSYTE AUTOGUARD BC UNIT FROM LOT NUMBER 3142661. ADDITIONALLY, TWO PHOTOS WERE PROVIDED. THROUGH THE VISUAL INSPECTION, ONLY THE CATHETER WAS RETURNED WHERE IT DISPLAYED A STRAIGHT HORIZONTAL CUT NEAR THE TIP OF THE CATHETER TUBE. A LEAK TEST WAS PERFORMED TO CONFIRM THAT THE CUT CAUSED A LEAK. THE CATHETER TIP QUALITY WAS ALSO INSPECTED AND CONFIRMED AS ACCEPTABLE. THE REPORTED ISSUE WAS CONFIRMED AND DETERMINED TO BE MANUFACTURING RELATED. DURING CATHETER TIPPING, THE CATHETER TIP IS FORMED. TUBING DAMAGE MAY OCCUR DUE TO MANDREL INSERTION WHICH MAY RESULT IN LEAKAGE DURING INSERTION OF THE DEVICE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. H3 OTHER TEXT: SEE NARRATIVE BELOW.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    ADD INFO RECEIVED FROM CUSTOMER: THE RN THAT PROVIDED THE COMPLIANT PROVIDED THE INFORMATION BELOW: WAS THERE ANY PATIENT INVOLVEMENT? [XXX, RN, BSN, CMSRN] THE IV WAS GETTING READY TO BE PLACED IN PT, BECAUSE THE NURSE NOTICED THE DEFECT, PRODUCT WAS NOT USED. IF YES, WHAT IS THE PATIENT OUTCOME? ARE THERE ANY ADVERSE EVENTS/SERIOUS INJURIES?[XXX, RN, BSN, CMSRN] PRODUCT DEFECT NOTED BEFORE USED ON PATIENT. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? [XXX RN, BSN, CMSRN] NO. WHAT TYPE OF PROCEDURE IS BEING PERFORMED? [XXX, RN, BSN, CMSRN] IV PLACEMENT WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? [XXX, RN, BSN, CMSRN] NA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: ONE OF OUR NURSE MANAGERS CAME DOWN TO LET ME KNOW THEY HAVE SEEN THE TIP BREAK/BEND ON A COUPLE OF THE 20GAX1 CATHETERS. PLEASE SEE THE ATTACHED PICTURES. THEY SAVED A NEW ONE FOR ME TO SHOW ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500709 BD INSYTE AUTOGUARD INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3142661 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown