BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE BL 22GA X 1.0IN

    MDR report key: 22063391 · Received May 21, 2025

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    Report

    Report Number
    2243072-2025-00667
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    April 9, 2025
    Report Date
    May 29, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903812233
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). FOLLOW UP REPORT FOR CORRECTION. ANNEX A CODE WAS INCORRECT IN THE INITIAL MDR. ANNEX A CODE SHOULD BE A24 - ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. ANNEX E CODE WAS INCORRECT IN THE INITIAL MDR. ANNEX E CODE SHOULD BE E0141 - PNEUMOCEPHALUS. ANNEX F CODE WAS INCORRECT IN THE INITIAL MDR. ANNEX F CODE SHOULD BE F12 - SERIOUS INJURY/ ILLNESS/ IMPAIRMENT.

    Additional Manufacturer Narrative · 0

    D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. G.1. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. AS NEITHER A LOT NUMBER NOR A SAMPLE WAS AVAILABLE FOR THIS INCIDENT, A COMPLETE INVESTIGATION COULD NOT BE CONFIRMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE BL 22GA X 1.0IN HAD AIR BUBBLES / AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A 45-YEAR-OLD PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2025 FOR A SEIZURE ON THE STAIRS WITH LOSS OF CONSCIOUSNESS AND A FALL IN THE PRESENCE OF CARDIAC DISEASE. A VVP WAS INSERTED IN ZAO Å I LH FOR BIOLOGICAL SAMPLING IN THE CUBICLE, AND PERFALGAN IV 1000 MG WAS ADMINISTERED OVER 10 MINUTES BY GRAVITY INFUSION AT AROUND 12.15PM. WHEN NOT IN USE, THE CATHETER WAS BLOCKED BY AN EXTENSION TUBE WITH A BIDIRECTIONAL MICROCLAVE VALVE. THE PATIENT'S NEUROLOGICAL OF THE PATIENT'S NEUROLOGICAL CONDITION IN THE EMERGENCY DEPARTMENT, IDEOMOTOR SLOWING AND SPEECH PARAPHASIAS WITHOUT ANY OTHER DEFICIT, A BRAIN SCAN PERFORMED WITHOUT INJECTION REVEALED NO ISCHAEMIC OR HAEMORRHAGIC LESIONS, BUT AIR BUBBLES SITUATED IN THE CAVERNOUS SINUS WHICH, THE RADIOLOGIST HYPOTHESISED, MIGHT BE SECONDARY TO THE INSERTION OF A VVP. A GAS EMBOLISM WAS SUSPECTED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR FURTHER MANAGEMENT. HYPERBARIC OXYGEN THERAPY WAS RECOMMENDED, WITH THE TRENDELENBOURG POSITION AND HIGH-FLOW OXYGEN THERAPY AT 15 1/MIN IN BETWEEN. NEUROLOGICALLY, FOLLOWING THE HYPERBARIC OXYGEN THERAPY SESSION, HE SHOWED COMPLETE NEUROLOGICAL RECOVERY. HE REMAINED SLIGHTLY ASTHENIC WITH NO MOTOR DEFICIT. HE WAS THEN TRANSFERRED TO CARDIOLOGY ON (B)(6) 2025 FOR MANAGEMENT OF HIS INITIAL MALAISE AND AN AETIOLOGICAL ASSESSMENT. AT THE TIME OF TRANSFER, THE EMERGENCY DOCTOR POINTED OUT THAT, GIVEN THE BACKGROUND OF HEART DISEASE, THE HYPOTHESIS OF A PFO COULD ALSO EXPLAIN THE SYMPTOMS AND THE CHANCE DISCOVERY OF THESE AIR BUBBLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798174 BD INSYTE BL 22GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN 00382903812233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other