MAUDE Adverse Event Report: CONMED UTICA POOLE; TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Catalog Number	0035040
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During incoming inspection, the distributor rejected this device, 0035040, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This will be reported as a malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
An examination of returned unused device (b)(4) found that there was an insufficient heat-seal.Dye leak test was not needed as the insufficient seal was visually observable on both devices.Root cause cannot be determined, however, based upon evaluation of the device, a possible cause of this event is the device was encroaching into the seal.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.A two-year lot history review shows a total of two (2) devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 43 reports, regarding 129 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).We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: POOLE
• Common Device Name: TUBE, ASPIRATING, FLEXIBLE, CONNECTING
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 21178367
• Report Number: 1320894-2025-00022
• Device Sequence Number: 11837268
• Product Code: BYY
• UDI-Device Identifier: 10653405000389
• UDI-Public: (01)10653405000389(17)280429(10)202305011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/16/2025

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: Other
• Device Catalogue Number: 0035040
• Device Lot Number: 202305011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic