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

Model Number	7318
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that ray-tec sponges were inspected prior to use at the or general surgery.During inspection, two ray-tec sponges from a package of ten were found to have fiber separating and shedding.The management was notified immediately upon discovery.The surgical team was made aware and remained vigilant throughout the procedure, regularly checking for any potential fiber shedding to ensure no material was retained.The issue was noticed during preparation and both affected ray-tec sponges were immediately removed from the sterile back table and not used on the patient.
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 ; 5086183640
• MDR Report Key: 24875309
• Report Number: 1423537-2026-00109
• Device Sequence Number: 15691319
• Product Code: GDY
• UDI-Device Identifier: 20192253047292
• UDI-Public: (01)20192253047292(10)25L018262
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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: 25L018262
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 06/23/2026
• 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