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

Model Number	4310
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the initial reporter, a microbiology brush was used on a patient for bronchoscopy.While taking the brush sample, the blue plastic tear drop tip on the distal end of the brush came off and fell into the patient's bronchus.The plastic tip was removed with suction, and no major damage was visible.

• 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: 17617995
• Report Number: 1220592-2023-00004
• Device Sequence Number: 16805729
• Product Code: FDX
• UDI-Device Identifier: M84943100
• UDI-Public: M84943100
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4310
• Device Catalogue Number: 4310
• Device Lot Number: H10-22-072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2023
• 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
• Patient Sex: Unknown