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 Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "n the middle of surgery, the surgeon noticed that the string of a cottonoid was getting suctioned and when they pulled it out, they only recovered the string and not the entire cottonoid.The or team was informed of the missing cottonoid and immediate actions were performed.Help was called to help search the or environment, the manifold of the neptune suction machine was opened to check if it was there, the suction tubing was visually checked and flushed but it was not there too, the kick bucket was checked and all the raytechs inside the kick bucket was individually inspected for the missing cottonoid, c-arm was already in use so multiple xray views were taken (lateral and ap), another cottonoid was placed temporarily to have a visual representation of what a cottonoid looks like under xray.After the surgeon explored the wound, they finally found the missing cottonoid but it was missing a corner.Information- was sent via email to the or manager.Surgeon irrigated the surgical wound copiously and was informed to document and inform the family of the patient about the said incident.The time when the cottonoid was lost and eventually finding it happened while the surgical incision was still open and it was not time to do a closing count yet".It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Cottonoid detached from string during surgery.

• 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: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24344979
• Report Number: 1417592-2026-00125
• Device Sequence Number: 10005359
• Product Code: HBA
• UDI-Device Identifier: 20080196286659
• UDI-Public: 20080196286659
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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
• Device Catalogue Number: NEUROSPNG05
• Device Lot Number: 6052501003
• 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: 01/20/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2026
• 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: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White