MAUDE Adverse Event Report: JIANERKANG MEDICAL CO LTD CARDINAL HEALTH; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	23250-407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.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; therefore, the affected device could not be evaluated to confirm the reported failure.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.
Event or Problem Description
It was reported that post-operatively, a laparotomy sponge was retained in the patient following a surgical procedure, necessitating a second surgery to retrieve the sponge.The retained sponge resulted in extended patient's hospitalization by 3-4 days.An x-ray was taken to assist in locating the retained sponge.Patient was initially taken to intensive care unit but had to return due to complications.The sponge was fully retrieved during the second surgery.It was noted that the sponge count was correct, and machine read a correct count at the end of the initial procedure but did not detect a sponge was in the patient.Event date and initial reporter were unknown.
Additional Manufacturer Narrative
Supplemental report is being filed due to the manufacturer name and address in d3, f14, and g-contact office manufacturing site on the initial report 1423537-2025-00231 were entered incorrectly.The correct manufacturer name and address are now being submitted in those fields.No other changes to the report are required.

• Brand Name: CARDINAL HEALTH
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): JIANERKANG MEDICAL CO LTD; no.1, jianerkang road, zhixi; jiangsu province; jintan district changzhou city 21325 1; CH 213251
• Manufacturer (Section G): JIANERKANG MEDICAL CO LTD; no.1, jianerkang road, zhixi; jiangsu province; jintan district changzhou city 21325 1; CH 213251
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 22154585
• Report Number: 1423537-2025-00231
• Device Sequence Number: 9382698
• Product Code: GDY
• UDI-Device Identifier: 30885380121702
• UDI-Public: 30885380121702
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 23250-407
• Device Catalogue Number: 23250-407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/13/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown