MAUDE Adverse Event Report: MEIXIN MEDICAL SUZHOU CO. , LTD PNUT SP-PEEL-ST 5'S-250 SP/CS, X-RAY DETECTABLE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	30-106
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported, "peanut sponge supply (reference # (b)(4)) blue radiopaque fiber flaked off during procedure.".
Additional Manufacturer Narrative
An unknown user facility reported, "peanut sponge supply (reference # (b)(4) ) blue radiopaque fiber flaked off during procedure." because the facility was unknown, return of the device was unavailable.A supplier corrective action request (scar) was issued to the supplier, (b)(4).The investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information is available.
Additional Manufacturer Narrative
An unknown user facility reported, "peanut sponge supply (reference # 30-106) blue radiopaque fiber flaked off during procedure." because the facility was unknown, return of the device was unavailable.It was initially reported that a supplier corrective action request (scar) was issued to the supplier, meixin medical, however, it was realized that the blue material being referenced here was referring to the foam holder that deroyal supplies so no scar was necessary.Work instructions for the peanut sponge with foam holder were reviewed and found to be 100% verified and any found with defects are discarded.The assembled product then goes through the packaging process and a final inspection is performed and the product is released if found to be passing all inspections.The device history record (dhr) for the lot reported was reviewed and no issues were found.An inventory check was performed on (b)(4) eaches of raw material and (b)(4) eaches of finished goods and no issues were found.A complaint to sales ratio was conducted from january 2023 to september 2025 and was found to be (b)(4).Root cause: because the sample was unavailable for return and no issues were found in the production records, the root cause was unable to be determined.Corrective and preventive actions: because the root cause was unable to be determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this item and issue.The investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: PNUT SP-PEEL-ST 5'S-250 SP/CS, X-RAY DETECTABLE
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): MEIXIN MEDICAL SUZHOU CO. , LTD; tuncun industrial zone; tongil town, wujiang; suzhou, 21521 6; CH 215216
• Manufacturer (Section G): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 22629868
• Report Number: 3004605321-2025-00011
• Device Sequence Number: 7994794
• Product Code: GDY
• UDI-Device Identifier: 00749756024280
• UDI-Public: 00749756024280
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: 30-106
• Device Lot Number: 61734981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/10/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown