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

Catalog Number REF SBA11LAMM4

Device Problems Component Missing (2306); Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 08/31/2021

Event Type  malfunction  

Event Description

Laparotomy pack sponge count is usually 5, but this pack contained only 4.Fda safety report id# (b)(4).

• Brand Name: CARDINAL HEALTH PRESOURCE
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; waukegan IL 60085
• MDR Report Key: 13118641
• MDR Text Key: 283139212
• Report Number: MW5106381
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: REF SBA11LAMM4
• Device Lot Number: 670640
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1