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

Model Number 181A321

Device Problems Contamination /Decontamination Problem (2895); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  malfunction  

Event 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
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12066205
• MDR Text Key: 258364005
• Report Number: 12066205
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00193493997947
• UDI-Public: (01)00193493997947(240)109979402(17)220915(10)30114617
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 06/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1