MAUDE Adverse Event Report: AVANOS; ANESTHESIA CONDUCTION KIT

Model Number	99794
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Sterility issue: after opening avanos universal block tray ref#(b)(4) lot#20023460 exp.2022-06-01; a black hair was discovered in pack.Pack removed and new set up began prior to patient entering operating room.

• Brand Name: AVANOS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10464862
• Report Number: 10464862
• Device Sequence Number: 11543091
• Product Code: CAZ
• UDI-Device Identifier: 00193493997947
• UDI-Public: (01)00193493997947(240)109979402(17)220604(10)20023460
• 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): 08/10/2020
• Report Date (Section F): 08/10/2020

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: 99794
• Device Catalogue Number: 181A432
• Device Lot Number: 20023460
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/10/2020