MAUDE Adverse Event Report: CONMED UTICA FRAZIER; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Catalog Number	0033120
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
Received 6 of item 0033120 in unopened original packaging.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 per tm-10-217 rev.F which indicated that the packaging had insufficient heat seal on 3 packages as there was leakage.The remaining 3 devices had no leakage.A root cause cannot be determined; however, based upon evaluation of the device, a possible of this event could be that the packages were improperly sealed.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 (b)(4) for this lot number and failure mode; however, none were confirmed.A two-year review of complaint history revealed there has been a total of (b)(4), for this device family and failure mode.During this same time frame (b)(4) 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
The distributor reported that the 0033120 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.Update: 19 feb 2025 - the device has been returned and an evaluation has been completed.An insufficient heatseal was discovered after testing.This will be reported as a malfunction with potential for injury upon reoccurrence.

• Brand Name: FRAZIER
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 21617362
• Report Number: 1320894-2025-00075
• Device Sequence Number: 12890572
• Product Code: GCX
• UDI-Device Identifier: 30653405000147
• UDI-Public: (01)30653405000147(17)271204(10)202212051
• 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,Company Representative
• 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: 0033120
• Device Lot Number: 202212051
• 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: 02/20/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic