MAUDE Adverse Event Report: CONMED CORPORATION; TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Model Number	0036550
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Conmed tubing, unopened package with evidence of hair, visible through packaging.

• Brand Name: NA
• Common Device Name: TUBE, ASPIRATING, FLEXIBLE, CONNECTING
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 10277550
• Report Number: 10277550
• Device Sequence Number: 2697813
• Product Code: BYY
• UDI-Device Identifier: 10653405000525
• UDI-Public: (01)10653405000525(17)250219(10)202002215
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/25/2020
• Report Date (Section F): 06/25/2020

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: No Information
• Device Model Number: 0036550
• Device Catalogue Number: 0036550
• Device Lot Number: 202002215
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/25/2020