MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; SPONGE,NEURO,0.5"X0.5",XR,STRL,10/PK

Catalog Number	NEUROSPNG05
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Update to h6: investigation findings (c).Update to h6: investigation conclusions (d).
Additional Manufacturer Narrative
According to the customer, (b)(6) 2025 it was discovered that the string was missing from a cottonoid sponge while removing it from the surgical site.The customer said "the string had been suctioned into the neptune machine" and was recovered from the neptune manifold.The customer confirmed that all pieces of the cottonoid were recovered and the procedure was able to be completed.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, (b)(6) 2025 it was discovered that the string was missing from a cottonoid sponge while removing it from the surgical site.The customer said "the string had been suctioned into the neptune machine" and was recovered from the neptune manifold.The customer confirmed that all pieces of the cottonoid were recovered and the procedure was able to be completed.

• Brand Name: MEDLINE
• Common Device Name: SPONGE,NEURO,0.5"X0.5",XR,STRL,10/PK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24053260
• Report Number: 1417592-2026-00038
• Device Sequence Number: 13197886
• Product Code: HBA
• UDI-Device Identifier: 20080196286659
• UDI-Public: 20080196286659
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NEUROSPNG05
• Device Lot Number: 6052502005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White