BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ASPIRATING NEEDLE

    MDR report key: 16846813 · Received May 1, 2023

    Report

    Report Number
    1220592-2023-00003
    Event Type
    Injury
    Date Received
    May 1, 2023
    Date of Event
    March 29, 2023
    Report Date
    May 1, 2023
    Manufacturer
    HOBBS MEDICAL, INC.
    Product Code
    GAA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNABLE TO OBTAIN CLARIFICATION ON CATALOG NUMBER OR LOT INFORMATION TO HELP DETERMINE IF THE SUBJECT DEVICE WAS INDEED A HOBBS MEDICAL PRODUCT.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHILE OBTAINING THE BIOPSY WITH THE NEEDLE, THE PHYSICIAN REPORTED FEELING A POP. AFTER RETRACTING THE BRONCHOSCOPE, THE SHEATH REPORTEDLY UNWEDGED AND THE PATIENT'S HEART RATE SPIKED TO APPROXIMATELY 190. THE PATIENT RETURNED TO SINUS RHYTHM WITHIN A MINUTE OR TWO. PATIENT RECEIVED A STAT ELECTROCARDIOGRAM (ECG) BY CARDIOLOGIST. PNEUMOTHORAX WAS FOUND WHEN A CHEST X-RAY WAS PERFORMED. PATIENT WAS ASYMPTOMATIC, HOWEVER, A CHEST TUBE PLACED, AND THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418046 UNKNOWN ASPIRATING NEEDLE ASPIRATING NEEDLE GAA HOBBS MEDICAL, INC. UNKNOWN ASPIRATING NEEDLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H