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

Model Number	0036550
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Conmed suction tubing, sterile packet opened.When the end of the tubing was visualized- a black substance was noted inside.It was a large amount of thick, black debris attached to the inside of the tubing.This was not attached to suction so no patient harm.Manufacturer response for tube, aspirating, flexible, connecting, na (per site reporter) will obtain.

• Brand Name: NA
• Common Device Name: TUBE, ASPIRATING, FLEXIBLE, CONNECTING
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 16843369
• Report Number: 16843369
• Device Sequence Number: 6823149
• Product Code: BYY
• UDI-Device Identifier: 10653405000525
• UDI-Public: (01)10653405000525(17)270516(10)202205175
• 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): 04/14/2023
• Report Date (Section F): 04/14/2023

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: Health Professional
• Device Model Number: 0036550
• Device Catalogue Number: 0036550
• Device Lot Number: 202205175
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/14/2023