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

Model Number SEN7CHNYNM

Device Problem Component Missing (2306)

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

Event Date 08/29/2022

Event Type  No Answer Provided  

Event Description

A minor head and neck pack was used for the setup of a parotidectomy.One set of raytec sponges is supposed to come with this pack.While performing the initial count with the circulating nurse, the scrub nurse counted 9 raytecs (rather than a complete set of 10).The counts were performed again to verify that a full set of raytec sponges had not come with the pack.Pack ref# sen7chnynm, pack lot# 873770.Manufacturer response for sponge pack, head and neck pack (per site reporter) informed representative.

• Brand Name: CARDINAL HEALTH
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 15787618
• MDR Text Key: 303546076
• Report Number: 15787618
• Device Sequence Number: 1
• Product Code: LRO
• 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: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: SEN7CHNYNM
• Device Catalogue Number: SEN7CHNYNM
• Device Lot Number: 873770
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1