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

Model Number SOP56TK80H

Device Problem Dull, Blunt (2407)

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

Event Date 01/08/2020

Event Type  malfunction  

Event 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
• Type of Device: ORTHOPEDIC TRAY-KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 9753470
• MDR Text Key: 180867179
• Report Number: 9753470
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10888439420388
• UDI-Public: (01)10888439420388
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SOP56TK80H
• Device Catalogue Number: SOP56TK80H
• Device Lot Number: 340859
• 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: 01/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 74