BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IAG BC PRO GLOBAL YEL 24GA X .75IN

    MDR report key: 18655316 · Received February 6, 2024

    Report

    Report Number
    1710034-2024-00084
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    January 31, 2024
    Report Date
    May 15, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF A LEAK COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE SAMPLES THAT WERE PROVIDED FOR INVESTIGATION. FOURTEEN 24G INSYTE AUTOGUARD UNITS WERE RECEIVED IN SEALED PACKAGING FROM LOT #3240092. A FUNCTIONAL TEST REVEALED NO DAMAGE OR DEFECTS FROM THE UNUSED 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. THE INSTRUCTIONS FOR USE (IFU) STATE, "NOTE: BLOOD FLOW FROM THE CATHETER HUB WILL BE RESTRICTED IMMEDIATELY AFTER NEEDLE RETRACTION UNTIL A SECURE LUER CONNECTION IS MADE. WARNING: LEAVING THE NEEDLE TIP WITHIN THE CATHETER HUB FOR A PROLONGED PERIOD MAY RESULT IN BLOOD LEAKAGE. WARNING: DO NOT LEAVE CATHETER HUB EXPOSED WITHOUT CONNECTING TO AN ACCESSORY DEVICE. BLOOD LEAKAGE FROM THE CATHETER HUB MAY OCCUR UNLESS A SECURE LUER CONNECTION IS MADE WITHIN 10 SECONDS."

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: 1. WAS THE BLOOD LEAKAGE OCCURRING AT THE HUB ON THE DEVICE? IT WAS ACTUALLY THE IV FLUID LEAKING OUT OF WHAT SEEMED LIKE THE BASE OF THE CATHETER DESPITE ENSURING THE LUER CONNECTION WAS TIGHT 2. HOW SOON AFTER NEEDLE RETRACTION WAS A LUER CONNECTION MADE? THE LUER CONNECTION WAS MADE IMMEDIATELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE BD IAG BC PRO GLOBAL YEL 24GA X .75IN CATHETERS ARE LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " THE BLOOD DOESN'T STOP AS IT'S SUPPOSED TO DO. THE CATHETERS WERE LEAKY AS IN WHEN I STARTED THE IVS, THE IV FLUID WOULD LEAK OUT ONTO THE ARM RATHER THAN GO INTO THE VEIN DESPITE PROPER CATHETER INSERTION. DIRECTLY WHILE USING IT WITH THE PATIENT. CHANGE OF TREATMENT IN TERMS OF WE HAD TO USE A DIFFERENT CATHETER TO AVOID SPILLING BLOOD ALL OVER THE ROOM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495914 BD IAG BC PRO GLOBAL YEL 24GA X .75IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3240092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown