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

Model Number SNE7CSHYNO

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2022

Event Type  malfunction  

Event Description

Shunt pack (b)(4) lot# 928317 was found to have only 4 lap sponges in one of the 2 packs.The sponges were passed off the field and sequestered in the or service lead office.

• Brand Name: CARDINAL HEALTH
• Type of Device: NEUROLOGICAL TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 16310874
• MDR Text Key: 308921957
• Report Number: 16310874
• Device Sequence Number: 1
• Product Code: OJG
• 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: 01/30/2023

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: SNE7CSHYNO
• Device Catalogue Number: SNE7CSHYNO
• Device Lot Number: 928317
• 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: 01/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1