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	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the sponges are flaking small fibers/debris.The fear is foreign body in the wound.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed and no anomalies related to the reported issue were observed.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.There were no samples returned for evaluation.Instead, one photo was provided for review which only shows the lint but not the product therefore the exact root cause could not be identified.The physical sample is required for further investigation.We will continue to monitor related reports to determine if additional actions are necessary.

• 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: 22188862
• Report Number: 1423537-2025-00241
• Device Sequence Number: 15607592
• Product Code: GDY
• UDI-Device Identifier: 20192253047285
• UDI-Public: (01)20192253047285(17)300228(10)23C019262
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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): 10/15/2025

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: 25C019262
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 10/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown