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

Model Number SBA12LPMFL

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2023

Event Type  malfunction  

Event Description

During initial count for surgical procedure, raytec sponges included in basic set up surgical pack noted to be eight counts instead of ten count.Raytecs recounted three times by scrub tech and circulator.Raytecs removed from table.Alternate package of ten opened and count confirmed.

• Brand Name: CARDINAL HEALTH
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 16520810
• MDR Text Key: 311056726
• Report Number: 16520810
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SBA12LPMFL
• Device Catalogue Number: SBA12LPMFL
• Device Lot Number: 968474
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1