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	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A distributing facility reported, "during a case one or the neuro patty sponges came apart in the patient." (b)(4) requested the return of the device but it is not received.A supplier corrective action request (scar) is to be issued to the supplier.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 distributing facility reported, "during a case one or the neuro patty sponges came apart in the patient.".
Additional Manufacturer Narrative
A distributing facility reported, "during a case one or the neuro patty sponges came apart in the patient." deroyal industries requested the return of the device but it was no received.A supplier corrective action request (scar) was issued to the supplier.Deroyal industries, inc.Reviewed three work orders that used the lot number provided, each work order was found to have no discrepancies.Inventory would be inspected; however, no inventory was on hand to inspect.A complaint to sales ratio was completed from december 2022 to december 2024 and found to be 0.0014%.The supplier returned the scar after completing their investigation.The supplier reviewed the device history record and found that all met the established acceptance criteria.Root cause: because the device was not available for return and no issues could be found within the device history record or manufacturing, the root cause was not able to be established.Corrective and preventive actions: because no root cause was able to be determined, no specific corrective or preventive actions were taken.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 industriial park; san pedro de marcoris, ; DR
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 20945543
• Report Number: 1060680-2024-00007
• Device Sequence Number: 19961717
• Product Code: EFQ
• UDI-Device Identifier: 00749756037242
• UDI-Public: 00749756037242
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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
• Operator of Device: Health Professional
• Device Model Number: 30-054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 02/18/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown