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	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint was created due to the receipt of a medwatch report mw5152454 on 25mar24.The report was found to be written against the 000140, harrell 7mm bronch brush (20/cs) device that was being used during an unknown procedure on 27feb24.The report stated, ¿head came off inside patients left lower lobe, doctor retrieved it using ion cath, pulmonary forceps and therapeutic bronchoscope.¿.There was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
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.(b)(4).Per the instructions for use, the user is advised to 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.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report mw5152454 on 25mar24.The report was found to be written against the 000140, harrell 7mm bronch brush (20/cs) device that was being used during an unknown procedure on (b)(6) 2024.The report stated, ¿brush head came off inside patients left lower lobe, doctor retrieved it using ion cath, pulmonary forceps and therapeutic bronchoscope." there was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 19164023
• Report Number: 3007305485-2024-00061
• Device Sequence Number: 7303967
• Product Code: GEE
• UDI-Device Identifier: 10653405051091
• UDI-Public: (01)10653405051091(17)280416(10)202304184
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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: 202304184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic