MAUDE Adverse Event Report: JIANERKANG MEDICAL CO., LTD, CARDINAL HEALTH; LAP SPONGE

Model Number	23250-407
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
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.
Additional Manufacturer Narrative
The production process was investigated.During the production, there were four steps for confirming the product quantity.The customer did not provided the defective batch and samples.The customer did not notice any miscount either.Therefore, the affected device could not be evaluated to confirm the reported failure.As such, a root cause could not be determined.

• Brand Name: CARDINAL HEALTH
• Common Device Name: LAP SPONGE
• Manufacturer (Section D): JIANERKANG MEDICAL CO., LTD,; no.1 jianerkang road, zhixin; town, industrial zone, jintan; changzhou, jiangsu 21325 1; CH 213251
• Manufacturer (Section G): JIANERKANG MEDICAL CO., LTD.; no.1, jianerkang road, zhixi; town industrial zone jintan; changzhou, jiangsu 21325 1; CH 213251
• MDR Report Key: 22286608
• Report Number: 9616874-2025-00001
• Device Sequence Number: 8929638
• Product Code: GDY
• UDI-Device Identifier: 50885380121706
• UDI-Public: (01)50885380121706
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2025

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
• Operator of Device: Health Professional
• Device Model Number: 23250-407
• Device Catalogue Number: 23250-407
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown