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

Model Number	7148
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the raytecs inside the pack were coming apart.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A non-conformance review was conducted for lot 25e052362 and there were no ncs related to the reported event issued during the manufacturing of this lot.Based on the pictures provided the reported issue was confirmed.From the pictures it appears that the sponges were unraveled and show loose threads.The selvage edges should be within the folds of the gauze to prevent loose threads.There were no issues identified as part of the in-process inspections.This issue could potentially be a user error.Without physical samples, the ability to conduct a more comprehensive investigation into the precise nature of the complaint is limited.If samples are received at a later date, the investigation will be updated accordingly.At this time, no corrective and preventative action required.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: 23544102
• Report Number: 1423537-2025-00458
• Device Sequence Number: 9719373
• Product Code: GDY
• UDI-Device Identifier: 20192253047230
• UDI-Public: (01)20192253047230(10)25E052362
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 7148
• Device Catalogue Number: 7148-
• Device Lot Number: 25E052362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown