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

Model Number	SOP56TK80H
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Dull scalpel blades in the ortho tray-kit, unable to even cut through ioban skin drape on initial surgical incision.The blades within the pack are bard-parker rib-back, lot #0200156.All 6 blades from this pack were dull.Another pack was opened (same catalog # and lot#) that had at least 2 dull blades in the pack.Same lot # on all blades.

• Brand Name: CARDINAL HEALTH
• Common Device Name: ORTHOPEDIC TRAY-KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 9753470
• Report Number: 9753470
• Device Sequence Number: 2663995
• Product Code: OJH
• UDI-Device Identifier: 10888439420388
• UDI-Public: (01)10888439420388
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2020
• Report Date (Section F): 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: SOP56TK80H
• Device Catalogue Number: SOP56TK80H
• Device Lot Number: 340859
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 74
• Date Report Sent to FDA: 01/10/2020