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

Model Number SNE7CCRYNP

Device Problems Contamination of Device Ingredient or Reagent (2901); Unexpected Color (4055)

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

Event Date 03/14/2023

Event Type  malfunction  

Event Description

While setting up for a cranioplasty, it was noted during the count of the 1/2 x 3 neuropatties that some of them had brown spots on them.They were passed off the field.The surgeon was notified.The patties and the custom pack info were saved to be forwarded to materials.

• 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: 17315600
• MDR Text Key: 318940085
• Report Number: 17315600
• 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: 06/26/2023

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: SNE7CCRYNP
• Device Catalogue Number: SNE7CCRYNP
• Device Lot Number: 956815
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1