MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS ASPIRATION CATHETER; CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION

Model Number	92796
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
We went to use the aspiration catheter during an egd this morning and the tip would not open and close in order to get the aspirate we needed from the duodenum.We had to waste this supply and open a new one.Fda safety report id# (b)(4).

• Brand Name: AVANOS ASPIRATION CATHETER
• Common Device Name: CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION
• Manufacturer (Section D): AVANOS MEDICAL, INC.
• MDR Report Key: 15543039
• Report Number: MW5112418
• Device Sequence Number: 20337044
• Product Code: KDH
• UDI-Device Identifier: 00350770927961
• UDI-Public: (01)00350770927961
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2022

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: 92796
• Device Catalogue Number: 62290
• Device Lot Number: 30191400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown