BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBIOLOGY BRUSH

    MDR report key: 20257345 · Received September 18, 2024

    Report

    Report Number
    MW5159722
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    September 10, 2024
    Report Date
    September 16, 2024
    Manufacturer
    HOBBS MEDICAL INC.
    Product Code
    FDX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PT WAS HAVING A BRONCHOSCOPY PROCEDURE PERFORMED. THE PHYSICIAN WAS PERFORMING A CYTOLOGY BUSHING FOR TISSUE COLLECTION OF A TARGET SITE. AFTER THE CYTOLOGY BRUSHING FOR TISSUE COLLECTION OF A TARGET SITE. AFTER THE CYTOLOGY BRUSH WAS REMOVED, THE PHYSICIAN VISUALIZED THE BLUE TIP OF THE CYTOLOGY BRUSH IN THE BRONCHIAL "TREE." ATTEMPTS TO LOCATE AND REMOVE WERE UNSUCCESSFUL. CHEST X-RAYS AND CHEST CT SCANS WERE PERFORMED WITHOUT IDENTIFYING BLUE TIP OF CYTOLOGY BRUSH. THIS WAS PROBABLY DUE TO THIS SMALL SIZE. NOT APPARENT INJURY OR AFFECT TO PT. REPORTED OUT OF AN ABUNDANCE OF CAUTION AND F/U.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296334 MICROBIOLOGY BRUSH ENDOSCOPIC CYTOLOGY BRUSH FDX HOBBS MEDICAL INC. HO5-22-008

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female ASPIRIN 81 MG = 1 TAB, ORAL DAILY| CARVEDILOL 6.25 MG = 1 TAB, ORAL, BID| EZETIMIBE 10 MG - 1 TAB, ORAL, Q BEDTIME | MONTELUKAST (SINGULAIR) 10 MG = 1TAB, ORAL, QAM | RIVAROXABAN 2.5 MG = 1 TAB, ORAL BID | ROSUVASTATIN 40 MG = 4 TAB, ORAL, Q EVENING | SODIUM CHLORIDE (SODIUM CHLORIDE 0.9Z% FLUSH) 10 ML, IV PUSH, Q 8 HR| VALSARTAN 80 MG 1 TAB, ORAL, DAILY