BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBIOLOGY BRUSH

    MDR report key: 20667329 · Received November 12, 2024

    Report

    Report Number
    1220592-2024-00006
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    September 10, 2024
    Report Date
    November 12, 2024
    Manufacturer
    HOBBS MEDICAL, INC.
    Product Code
    FDA
    PMA / PMN Number
    K893729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FACILITY, EVENT DATE, REPORTED PROBLEM, AND PRODUCT TYPE ARE THE SAME AS THOSE COMMUNICATED IN A COMPLAINT RECEIVED BY HOBBS MEDICAL VIA PHONE FROM THE REPORTER FACILITY ON THE SAME EVENT DATE AS EVENT REPORTED AS 1220592-2024-00005, BUT LOT NUMBER AND SPECIFIC PRODUCT CATALOG ARE DIFFERENT. CONTACTED CUSTOMER TO CONFIRM IF THE TWO REPORTS ARE IN FACT THE SAME EVENT, BUT CUSTOMER WAS NOT ABLE TO CONFIRM. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION AND WAS DISCARDED BY THE HEALTHCARE FACILITY. THE DEVICE IS INTENDED FOR USE IN THE GASTROINTESTINAL TRACT, NOT IN THE LUNGS. USE IN THE LUNGS IS THEREFORE CONSIDERED OFF-LABEL USE. MISBRANDED PRODUCTS WITHIN THIS PRODUCT FAMILY LABELED AS "BRONCHIAL" WERE RECALLED BY HOBBS MEDICAL IN 2021 (REF (B)(4) ), AND AFFECTED CONSIGNEES NOTIFIED. CONFIRMED THAT THE DEVICE LOT INVOLVED IN THIS COMPLAINT WAS PROPERLY LABELED FOR GASTROINTESTINAL USE.

    Description of Event or Problem · 0

    FDA NOTIFIED MANUFACTURER THAT A MEDWATCH REPORT HAD BEEN RECEIVED FROM A HEALTHCARE FACILITY. ACCORDING TO THE AUTHOR OF THE SUBMITTED REPORT, "THE PT WAS HAVING A BRONCHOSCOPY PROCEDURE PERFORMED. THE PHYSICIAN WAS PERFORMING A CYTOLOGY BUSHING (SIC) 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 (SIC) APPARENT INJURY OR AFFECT (SIC) TO PT. REPORTED OUT OF AN ABUNDANCE OF CAUTION AND F/U."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975842 MICROBIOLOGY BRUSH ENDOSCOPIC CYTOLOGY BRUSH FDA HOBBS MEDICAL, INC. H05-22-008

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other 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 = 1 TAB, ORAL QAM.| RIBAROXABAN 2.5 MG = 1 TAB, ORAL BID.| ROSUVASTATIN 40 MG = 4 TAB, ORAL Q EVENING.| SODIUM CHLORIDE 0.9Z% FLUSH 10 ML, IV PUSH, Q 8HR.| VALSARTAN 80 MG 1 TAB, ORAL, DAILY.