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

Model Number	7317
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the product was received with lint on it but the item claimed to be "lint free".On (b)(6) 2025 the customer clarified that these sponges are ¿shedding¿ they don¿t have lint on them.They are dropping shreds of the thin fibers.The customer stated that the product was being unfolded on the sterile field, but not over the patient, scrub tech noticed the ¿shedding¿ as the sponge was being unfolded over the mayo stand ¿ that was specifically lot# 25b023062 ¿ the sponge and remaining opened product used in the actual case was discarded.After the initial complaint they pulled another item of the same lot# to see if they could duplicate the issue.And they did, with normal opening it shed, with vigorous manipulation it shed a lot.
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 number 25b023062 and there were no ncs related to the reported event issued during the manufacturing of this lot.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.One sample was provided for evaluation and the reported issue was observed.A root cause was not able to be determined based on the available information however it does not appear to be manufacturing related.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: 21881209
• Report Number: 1423537-2025-00172
• Device Sequence Number: 21024904
• Product Code: GDY
• UDI-Device Identifier: 20192253047285
• UDI-Public: (01)20192253047285(17)300131(10)25B023062
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: 25B023062
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/03/2025
• 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