MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY HARRELL 7MM BRONCH BRUSH (20/CS); BRUSH, BIOPSY, GENERAL & PLASTIC SURGERY

Catalog Number	000140
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	01/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report (mw5151131) received on 21feb24.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against the 000140, harrell 7mm bronch brush (20/cs).The report states that on (b)(6) ¿during procedure dr.Utilized harrell unshealthed cytology brush (lot # 202303164) to attempt brushing of right lower lobe of lung.Upon withdrawal of disposable sheath, it was noted that the brush head was not attached.Dr.Used fluoroscopy to locate brush and removed with biopsy forceps.Brush head appeared intact.All brushes with this lot number were removed from room and stock at this time.¿ there was no injury or impact to the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report (mw5151131) received on 21feb24.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against the 000140, harrell 7mm bronch brush (20/cs).The report states that on 30jan24 ¿during procedure dr.Utilized harrell unshealthed cytology brush (lot # 202303164) to attempt brushing of right lower lobe of lung.Upon withdrawal of disposable sheath, it was noted that the brush head was not attached.Dr.Used fluoroscopy to locate brush and removed with biopsy forceps.Brush head appeared intact.All brushes with this lot number were removed from room and stock at this time.¿ there was no injury or impact to the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device has not been returned to date and no photographic evidence has been provided; therefore, the reported event cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of two reports, regarding two devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: inspect the peel-pouch for any damage that may have occurred during transit or handling.If damaged, do not use.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: HARRELL 7MM BRONCH BRUSH (20/CS)
• Common Device Name: BRUSH, BIOPSY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18847076
• Report Number: 3007305485-2024-00032
• Device Sequence Number: 7814250
• Product Code: GEE
• UDI-Device Identifier: 10653405051091
• UDI-Public: (01)10653405051091(17)280314(10)202303164
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

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 Catalogue Number: 000140
• Device Lot Number: 202303164
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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
• Patient Ethnicity: Non Hispanic