MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS; ANESTHESIA CONDUCTION KIT

Model Number 99794

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2020

Event Type  malfunction  

Event 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
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10464862
• MDR Text Key: 204735227
• Report Number: 10464862
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00193493997947
• UDI-Public: (01)00193493997947(240)109979402(17)220604(10)20023460
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 08/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1