MAUDE Adverse Event Report: MEDSORB DOMINICANA, S.A. NEURO-SP-1/2X1/2"-STRL 20/CS; GAUZE/SPONGE, INTERNAL

Model Number	30-054
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "during procedure, cst requested additional 1/2"x1/2" cottonoid patties be opened.Opened as requested.Shortly after, cst notified circulator that a cottonoid had the green stripe fall off.Circulator confirmed with cst that the cottonoid came from the freshly opened cottonoids, and not from the pack.Cst confirmed the faulty cottonoid was from the separately opened pack.Cst then checked all the 1/2" x 1/2" cottonoids on the field and found 1 additional cottonoid with a loose green stripe.Both faulty cottonoids removed from the field, both loose green stripes also removed from the field." deroyal industries, inc.Requested return of the device but has not yet received it.A supplier corrective action request (scar) has been issued to the supplier, (b)(4).This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.
Event or Problem Description
A user facility reported, "during procedure, cst requested additional 1/2"x1/2" cottonoid patties be opened.Opened as requested.Shortly after, cst notified circulator that a cottonoid had the green stripe fall off.Circulator confirmed with cst that the cottonoid came from the freshly opened cottonoids, and not from the pack.Cst confirmed the faulty cottonoid was from the separately opened pack.Cst then checked all the 1/2" x 1/2" cottonoids on the field and found 1 additional cottonoid with a loose green stripe.Both faulty cottonoids removed from the field, both loose green stripes also removed from the field.".
Additional Manufacturer Narrative
A user facility reported, "during procedure, cst requested additional 1/2"x1/2" cottonoid patties be opened.Opened as requested.Shortly after, cst notified circulator that a cottonoid had the green stripe fall off.Circulator confirmed with cst that the cottonoid came from the freshly opened cottonoids, and not from the pack.Cst confirmed the faulty cottonoid was from the separately opened pack.Cst then checked all the 1/2" x 1/2" cottonoids on the field and found 1 additional cottonoid with a loose green stripe.Both faulty cottonoids removed from the field, both loose green stripes also removed from the field.".Deroyal industries, inc.Requested return of the device, and it was received on 10/20/2025.Upon inspection the issue was confirmed as the green x-ray element was observed to be coming unattached.An inventory check was performed on one case of the raw material in stock and all were found to be acceptable.Because this is a purchased part, deroyal did not have a risk analysis to review.A complaint to sales ratio was conducted between october 2023 to october 2025 and found to be (b)(4).A supplier corrective action request (scar) will be issued to the supplier, (b)(4).The supplier reviewed the device history record (dhr) and reviewed a previous similar complaint.Due to the previous complaint, it was noticed that when material thickness variations would occur, the production associates would adjust the horn clearance but fail to verify if the adjustment was within the specified parameters.Within the previous complaint, corrective actions were taken, but this lot was manufactured prior to the implementation of those actions.Root cause: because the sample was not able to be determined, the specific root cause was not able to be determined, however, with the previous complaint, a potential root cause could be that when material thickness variations would occur, the production associates would adjust the horn clearance but fail to verify if the adjustment was within the specified parameters.Corrective and preventive actions: corrective and preventive actions were taken on the previous complaint and would also apply to this potential root cause.This previous complaint number (b)(4) and submitted with mdr # 1060680-2025-00004.These actions included: new horns with welder tips that provide more stability to the material.Additionally, work instructions were updated to mandate the verification of the distance between the horn and the anvil.With complaint specifically, a retraining was conducted for all the operators and supervisors on correct weld setup.Deroyal will continue to monitor for trends around this item and issue.This 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: NEURO-SP-1/2X1/2"-STRL 20/CS
• Common Device Name: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): MEDSORB DOMINICANA, S.A.; zona franca industrial park; san pedro de marcoris, ; DR
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 23290505
• Report Number: 1060680-2025-00052
• Device Sequence Number: 9926468
• Product Code: EFQ
• UDI-Device Identifier: 00749756037242
• UDI-Public: 00749756037242
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K791871
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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
• Operator of Device: Health Professional
• Device Model Number: 30-054
• Device Lot Number: 24102694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown