MAUDE Adverse Event Report: AVANOS; ANESTHESIA CONDUCTION KIT

Model Number	181A321
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Small piece of unknown debris found within a depression of a "universal block tray".Tray and sterile field replaced, "contaminated tray" removed, photographed and particle attached to the packaging from which it was removed.Product name: universal block tray.Tray and contents discarded; saved outer packaging and unknown debris (taped to packaging).

• Brand Name: AVANOS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 12066205
• Report Number: 12066205
• Device Sequence Number: 4988018
• Product Code: CAZ
• UDI-Device Identifier: 00193493997947
• UDI-Public: (01)00193493997947(240)109979402(17)220915(10)30114617
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2021
• Report Date (Section F): 06/10/2021

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
• Operator of Device: Health Professional
• Device Model Number: 181A321
• Device Catalogue Number: 181A321
• Device Lot Number: 30114617
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/10/2021