MAUDE Adverse Event Report: CONMED UTICA FRAZIER INSTRUMENT 10 FRENCH 50/CASE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	0033100
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, 0033100, 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
Reported event ¿insufficient heatseal & (sterile) pouch or blister pack¿ was confirmed.Received five 0033100 in original packaging.Lot numbers were verified.Performed a visual inspection of the devices, one of the device was not sealed at one end while the other three devices had no obvious signs of a breach in the package.Performed a functional inspection, the devices were dye leak tested which indicated that the packaging did have an insufficient heat 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 was conducted and found a total of 5 devices for this lot number.(b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: FRAZIER INSTRUMENT 10 FRENCH 50/CASE
• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16818067
• Report Number: 1320894-2023-00073
• Device Sequence Number: 17916290
• Product Code: GCX
• UDI-Device Identifier: 30653405000123
• UDI-Public: (01)30653405000123(17)270116(10)202201171
• 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): 04/26/2023

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 Model Number: 0033100
• Device Catalogue Number: 0033100
• Device Lot Number: 202201171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• 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