MAUDE Adverse Event Report: CARDINAL LB BASIC CUSTOM PACK GENERAL SURGERY TRAY

Catalog Number SBA24BCLCG

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2018

Event Type  malfunction  

Event Description

Incorrect sponge count in content of custom sterile procedure pack.

• Brand Name: LB BASIC CUSTOM PACK GENERAL SURGERY TRAY
• Type of Device: LB BASIC CUSTOM PACK GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL
• MDR Report Key: 7221328
• MDR Text Key: 98468084
• Report Number: MW5074869
• 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: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SBA24BCLCG
• Device Lot Number: 827515
• Was Device Available for Evaluation?: No
• 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