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
Additional Manufacturer Narrative
Performed a visual inspection of the devices, there were no obvious signs of a breach.Performed a functional inspection, the devices were dye leak tested which indicated that the packaging had insufficient heat seal on one of the packages as there was leakage.The second device did not have leakage.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 2 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 37 reports, regarding (b)(4) 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.
Event or Problem Description
Update 19feb25: the device was returned and evaluated.The completion of the device evaluation confirmed an insufficient heatseal; therefore, this complaint has been reassessed and meets the criteria for a reportable event.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.The distributor reported that the 0035040 device had an insufficient heatseal found during incoming inspection.No patient involvement occurred.The shipment associated with the rga for this device has not yet been returned for evaluation and it has not been confirmed that an insufficient heatseal causing a sterility breach has occurred.Based on the information available, and the decision tree results, this complaint does not meet the definition of a reportable event.Upon the receipt of the device, an evaluation will be conducted and if a breach of sterility is confirmed the reporting decision will be reassessed at that time.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 21617297
• Report Number: 1320894-2025-00074
• Device Sequence Number: 6734141
• Product Code: BYY
• UDI-Device Identifier: 10653405000389
• UDI-Public: (01)10653405000389(17)280408(10)202304101
• 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): 03/17/2025

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: 202304101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2023
• 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