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

Model Number	7317
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the product is linting really bad.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.Udi pi pending and will be added when available.
Additional Manufacturer Narrative
The device history record (dhr) for lot 25c055462 was reviewed and no anomalies related to the reported issue were observed.Based on the samples provided, the reported issue was observed.However the exact root cause was not determined but is most likely related to the manufacturing process.This could have been an isolated event incident as there were no issues identified as part of the in-process inspections therefore no corrective actions are necessary at this time.We will continue to monitor reports and take actions as applicable.

• 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 ; 5086183640
• MDR Report Key: 23042637
• Report Number: 1423537-2025-00365
• Device Sequence Number: 13229255
• Product Code: GDY
• UDI-Device Identifier: 20192253047285
• UDI-Public: (01)20192253047285
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: 7317
• Device Catalogue Number: 7317--
• Device Lot Number: 25C055462
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown