MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC ORP PEDIATRIC SURGERY PACK; GENERAL SURGERY TRAY

Model Number	SBAHDPSVCJ
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Pds surgical pack with unknown lint in 4x4 rfid sponges.

• Brand Name: ORP PEDIATRIC SURGERY PACK
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 18920594
• Report Number: 18920594
• Device Sequence Number: 20753716
• Product Code: LRO
• UDI-Device Identifier: 10197106474549
• UDI-Public: (01)10197106474549(11)231115(17)260601(10)178139
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/21/2024
• Report Date (Section F): 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SBAHDPSVCJ
• Device Catalogue Number: SBAHDPSVCJ
• Device Lot Number: 178139
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/21/2024