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

Model Number 0033100

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device in question has been received by conmed and has entered into the evaluation process.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

During incoming inspection, the distributor rejected this device, catalog # 0033100, lot 202006221, for a possible breach of sterility due to an insufficient heatseal.There was no contact with any patient as this was found during incoming inspection in (b)(6).The completion of the device evaluation confirmed an insufficient heatseal; therefore, this complaint meets the criteria for a reportable event.Due to the breach in sterility, this report is being raised as a malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Reported event of insufficient heat-seal is confirmed.Received eight 0033100 in original packaging.Lot number was verified.Performed a visual inspection of the device, there were no obvious signs of a breach.Performed a functional inspection, the devices were dye leak tested which indicated that the packaging had an insufficient heat seal on four out of the eight devices.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.(b)(4).Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

During incoming inspection, the distributor rejected this device, catalog # 0033100, lot 202006221, for a possible breach of sterility due to an insufficient heatseal.There was no contact with any patient as this was found during incoming inspection in japan.The completion of the device evaluation confirmed an insufficient heatseal; therefore, this complaint meets the criteria for a reportable event.Due to the breach in sterility, this report is being raised as a malfunction with potential for injury upon reoccurrence.

• Brand Name: FRAZIER INSTRUMENT 10 FRENCH 50/CASE
• Type of Device: 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: tracey weiselbenton ; conmed corporation; 11311 concept blvd; largo, FL 33773 ; 7273995557
• MDR Report Key: 12987744
• MDR Text Key: 283974489
• Report Number: 1320894-2021-00442
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 30653405000123
• UDI-Public: (01)30653405000123(17)250621(10)202006221
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

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
• Device Model Number: 0033100
• Device Catalogue Number: 0033100
• Device Lot Number: 202006221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic