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

Model Number 181A321

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 04/20/2022

Event Type  malfunction  

Event Description

All avanos universal block trays missing 1-lbl for nkt products.All of lot 30175885 affected.

• Brand Name: AVANOS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 14287856
• MDR Text Key: 290782061
• Report Number: 14287856
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00193493997947
• UDI-Public: (01)00193493997947(240)109979402(17)30175885
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/20/2022

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
• Device Model Number: 181A321
• Device Catalogue Number: 181A321
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1