MAUDE Adverse Event Report: CARDINAL HEALTH, INC. VISTEC; X-RAY DETECTABLE SPONGES, 16 PLY

Model Number	7148
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Raytec gauze missing radiopaque marker on one side of the gauze.Gauze was contained within roi cps, llc custom procedure kit-880085, lot 21116472691.Raytec was discarded and a new tub of gauze was pulled from inventory.No harm to patient and no delay to case.

• Brand Name: VISTEC
• Common Device Name: X-RAY DETECTABLE SPONGES, 16 PLY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 7000 cardinal place; dublin OH 43071
• Manufacturer (Section G): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4176473205
• MDR Report Key: 12800347
• Report Number: 3014527682-2021-00019
• Device Sequence Number: 5271058
• Product Code: GDY
• UDI-Device Identifier: 10884527016969
• UDI-Public: 10884527016969
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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
• Operator of Device: Health Professional
• Device Model Number: 7148
• Device Catalogue Number: 7148
• Device Lot Number: 20M081262,21A140762,21C050362
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown