MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC VISTEC; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	7318
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that upon opening the package of x-ray detectable sponges, there were 12 sponges in the package instead of 10.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: VISTEC
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 1430 marvin griffin road, po b; augusta GA 30906
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5082163840
• MDR Report Key: 25035135
• Report Number: 1423537-2026-00127
• Device Sequence Number: 15747176
• Product Code: GDY
• UDI-Device Identifier: 20192253047292
• UDI-Public: (01)20192253047292(10)25L018362
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: 7318
• Device Catalogue Number: 7318
• Device Lot Number: 25L018362
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/27/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown