MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; EAR, NOSE, AND THROAT SURGICAL TRAY

Model Number SEN7CMEY13

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

Major ent pack contained pack of raytec with 9 instead of 10.

• Brand Name: CARDINAL HEALTH
• Type of Device: EAR, NOSE, AND THROAT SURGICAL TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 18845623
• MDR Text Key: 336988031
• Report Number: 18845623
• Device Sequence Number: 1
• Product Code: OGR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SEN7CMEY13
• Device Lot Number: 161649
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1