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

Model Number SNE13NS96S

Device Problem Contamination (1120)

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

Event Date 06/07/2022

Event Type  malfunction  

Event Description

Narrative from staff: while setting up for an si fusion, all sets and equipment had been opened in usual sterile fashion and the operating room (or) nurse and scrub proceeded to count sponges and sharps per or policy prior to the procedure.While counting the raytec sponges it was discovered by the scrub tech that there was some unknown brown substance seemingly smeared in the middle of the stack of raytecs.Management and staff from the sterile core collaborated in agreement that the substance could not be identified and the whole back table and mayo stand should be torn down and set up again with all new sterile equipment and supplies.Manufacturer response for neurological tray, cardinal health (per site reporter) the rep said he submitted to the quality team and requested credit for the pack.They will also be sending a shipping label to send back the device.

• 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: 14684322
• MDR Text Key: 293956206
• Report Number: 14684322
• 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: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SNE13NS96S
• Device Catalogue Number: SNE13NS96S
• Device Lot Number: 802198
• 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: 06/10/2022
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16790 DA
• Patient Sex: Female
• Patient Weight: 104 KG