MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; EAR, NOSE, AND THROAT SURGICAL TRAY

Model Number SEN7CNAYNL

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

Nasal pack was opened for use in the patient's endoscopic sinus surgery.While the nurse and surgical tech were counting, the nurse noticed the rfd x-ray sponges looked different.On inspection the team realized the chip was missing from all the sponges, 10 in count.The sponges were removed from the field and replaced with rfd x-ray sponges before the patient was brought back for the surgery.Or notified mfg awaiting response.Manufacturer response for rfd x-ray sponges, (brand not provided) (per site reporter) or notified mfg rep directly.

• Brand Name: CARDINAL HEALTH
• Type of Device: EAR, NOSE, AND THROAT SURGICAL TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 18371101
• MDR Text Key: 331078373
• Report Number: 18371101
• Device Sequence Number: 1
• Product Code: OGR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/13/2023

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: SEN7CNAYNL
• Device Catalogue Number: SEN7CNAYNL
• Device Lot Number: 091410
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1