MAUDE Adverse Event Report: CARDINAL HEALTH TOTAL KNEE CUSTOM PACK ; GENERAL SURGERY TRAY

Catalog Number SOP24TKGMS

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2018

Event Type  malfunction  

Event Description

Holes found in 2 mayo covers which were in a custom pack.

• Brand Name: TOTAL KNEE CUSTOM PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 7506234
• MDR Text Key: 108229799
• Report Number: MW5077133
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SOP24TKGMS
• Device Lot Number: 865926
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1