BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION ASPIRATING NEEDLE

    MDR report key: 17634617 · Received August 28, 2023

    Report

    Report Number
    1220592-2023-00005
    Event Type
    Injury
    Date Received
    August 28, 2023
    Date of Event
    July 17, 2023
    Report Date
    August 28, 2023
    Manufacturer
    HOBBS MEDICAL, INC.
    Product Code
    GAA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT RECEIVED THROUGH DISTRIBUTOR OF SEVERAL HOBBS MEDICAL PRODUCTS AND OTHER PRODUCTS. UNCLEAR FROM THE REPORT WHETHER OR NOT A HOBBS MEDICAL DEVICE WAS IN FACT INVOLVED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT WAS VERY DIFFICULT TO INTUBATE DUE TO BEING FRAGILE POST-RADIATION. AFTER SAMPLING WAS COMPLETE, THE PHYSICIAN WAS SUCTIONING THE AIRWAYS AT THE END OF THE PROCEDURE AND THE PATIENT BEGAN TO BLEED. THERE WERE APPROXIMATELY 500 MILLIMETERS OF BLOOD LOSS AND THE NURSE ANESTHETIST WAS NOT ABLE TO VENTILATE. CHEST COMPRESSIONS FOLLOWED, PHYSICIAN GAVE EPINEPHRINE DOWN THE BRONCHOSCOPE AND THE NURSE GAVE EPINEPHRINE INTRAVENOUSLY. VENTILATION RESUMED AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU) STILL INTUBATED. THE PATIENT HAD PROLONG HOSPITALIZATION. REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329072 SUPERDIMENSION ASPIRATING NEEDLE ASPIRATION NEEDLE GAA HOBBS MEDICAL, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| O| H| R