MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; GENERAL SURGERY TRAY

Model Number SEN7CHNYN6

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/24/2022

Event Type  malfunction  

Event Description

During initial count, surgical tech found the head and neck pack had an incorrect number of raytecs included in the pack.There were 9 raytecs instead of 10.Lot# 685654.

• Brand Name: CARDINAL HEALTH
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 14345478
• MDR Text Key: 291291332
• Report Number: 14345478
• Device Sequence Number: 1
• Product Code: LRO
• 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: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SEN7CHNYN6
• Device Catalogue Number: SEN7CHNYN6
• Device Lot Number: 685654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1