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

Model Number SOP12KNMFM

Patient Problem Insufficient Information (4580)

Event Date 03/21/2024

Event Type  malfunction  

Event Description

Total knee pack found to have slice marks in back table cover.

• Brand Name: CARDINAL HEALTH
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 19123865
• MDR Text Key: 340361142
• Report Number: 19123865
• Device Sequence Number: 1
• Product Code: OJH
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SOP12KNMFM
• Device Catalogue Number: SOP12KNMFM
• Device Lot Number: 106150
• 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: 03/22/2024
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1