MAUDE Adverse Event Report: CONMED UTICA SOFT TIP FRAZIER INSTRM 10 FRENCH 20/CSE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	0031100
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
A visual inspection found one of three devices with an open hole in the seal caused by the device encroaching.The remaining two devices were encroaching into the seal of the packaging.The two devices with no open holes in the packaging were dye leak tested which indicated the packaging had 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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 51 complaints, regarding 93 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).Per the instructions for use, the user is advised the following: these devices should never be used when: there is visible evidence of damage to the exterior of the device such as cracked or damaged plastic.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
During incoming inspection, the distributor rejected this device, 0031100, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: SOFT TIP FRAZIER INSTRM 10 FRENCH 20/CSE
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• MDR Report Key: 12384720
• Report Number: 1320894-2021-00315
• Device Sequence Number: 4633640
• Product Code: GCX
• UDI-Device Identifier: 10653405000082
• UDI-Public: (01)10653405000082(17)250614(10)202006151
• 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: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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 Expiration Date: 06/14/2025
• Device Model Number: 0031100
• Device Catalogue Number: 0031100
• Device Lot Number: 202006151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1