MAUDE Adverse Event Report: MEDSORB DOMINICANA, S.A. NEURO SPNG-1/2X3"-STRL- 20/CS; GAUZE/SPONGE, INTERNAL

Model Number	30-057
Medical Device Problem Code	Extra Components (4067)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "1/2 x 3 neuro patties counted, and the pack had 11 when it should have been 10." deroyal industries, inc.Requested return of the device but it was not available.A supplier corrective action request (scar) will 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 user facility reported, "1/2 x 3 neuro patties counted, and the pack had 11 when it should have been 10.".
Additional Manufacturer Narrative
A user facility reported, "1/2 x 3 neuro patties counted, and the pack had 11 when it should have been 10." deroyal industries, inc.Requested return of the device, but it was not able to be returned.Deroyal reviewed the work order of the device and no issues were found.An inventory check was also performed on one case of the neurosponges.All pouches had the correct number of sponges and no issues were found.Because this is a purchased part, deroyal did not have a risk analysis to review.A complaint to sales ratio was conducted between may 2023 to may 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 manufacturing process of the neuro sponges.The work orders for the lot provided were reviewed and no further nonconforming product was found.The product was not returned and there was no work in progress to review.While the root cause was not specifically able to be confirmed because the sample was not returned, it was likely that this malfunction occurred because of an undetected overfill during manual packaging.The supplier reviewed training records and all employees were adequately trained, however the issue was most likely due to human error in the counting.Root cause: while the root cause was not specifically able to be confirmed because the sample was not returned, it was likely that this malfunction occurred because of an undetected overfill during manual packaging.Corrective and preventive actions: because the root cause was unable to be confirmed, the actions taken were based on a potential root cause.This included refresher training for all relevant personnel to emphasize counting steps and visual aids.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 SPNG-1/2X3"-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: 21986593
• Report Number: 1060680-2025-00025
• Device Sequence Number: 19905469
• Product Code: EFQ
• UDI-Device Identifier: 00749756035910
• UDI-Public: 00749756035910
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: 30-057
• Device Lot Number: 24102697
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 08/29/2025
• 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