MAUDE Adverse Event Report: HOBBS MEDICAL, INC. HOBBS MEDICAL MICROBIOLOGY BRUSH

Model Number	4310
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 z-0711-2022), and affected consignees notified.Confirmed that the device lot involved in this complaint was properly labeled for gastrointestinal use.A follow up report will be submitted when additional information on the patient's condition is received.
Event or Problem Description
It was reported that the distal atraumatic ball tip of the microbiology brush fell off which the device was in the patient's right upper lobe of the lung.According to the physician, they noticed the tip had fallen off while inside the lung and when the device was retracted from the scope, there was no tip on the device.Physician confirmed the tip was not lodged in the scope and did not feel it would be possible to suction the separated component out of the lung.Physician planned to send the patient for scans to identify the location of the tip in the lung.

• Brand Name: HOBBS MEDICAL MICROBIOLOGY BRUSH
• Common Device Name: MICROBIOLOGY BRUSH
• Manufacturer (Section D): HOBBS MEDICAL, INC.; 8 spring street; stafford springs CT 06076
• Manufacturer (Section G): HOBBS MEDICAL, INC.; 8 spring street; stafford springs CT 06076
• Manufacturer Contact: jennifer hodge ; 8 spring street; stafford springs, CT 06076 ; 8606845875
• MDR Report Key: 20309145
• Report Number: 1220592-2024-00005
• Device Sequence Number: 12978313
• Product Code: FDX
• UDI-Device Identifier: M84943100
• UDI-Public: +M84943100/$$0229H01243383
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K893729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4310
• Device Catalogue Number: 4310
• Device Lot Number: H01-24-338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown