MAUDE Adverse Event Report: CONMED CORPORATION BARON FRAZIER, 7 FRENCH, 50/C; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	0031070
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received in an unopened, original packaging.The reported catalog number and lot number were verified.Visual inspection of the device found a hole in the poly side of the component packaging.Dye leak testing found that the hole was through the poly and caused a breach of sterility.Due to the location of the hole and the sharp device component near the hole, it is likely that the breach was caused by the device from the inside out.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 were 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 13 complaints, regarding 42 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).It is standard medical practice to inspect all medical equipment prior to use.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The distributor in (b)(4) reported a "tear" on the sterile pouch of device (b)(4).This would be an obvious defect to the user and was therefore not deemed a reported device failure.However, the complaint device was returned to conmed for evaluation and a hole was found in the packaging that was likely caused by the device.No patient involvement as this defect was found during incoming inspection.This incident will be reported as a device malfunction with potential for injury.

• Brand Name: BARON FRAZIER, 7 FRENCH, 50/C
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 7613685
• Report Number: 1320894-2018-00152
• Device Sequence Number: 16500057
• Product Code: GCX
• UDI-Device Identifier: 30653405000079
• UDI-Public: (01)30653405000079(17)220611(10)201706121
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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: 06/11/2022
• Device Model Number: 0031070
• Device Catalogue Number: 0031070
• Device Lot Number: 201706121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1