MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; NEUROSURGICAL PADDIE

Model Number	NEUROSPNG05
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While removing a 1/2 x 1/2 cottonoid sponge from the surgical site, the scrub tech discovered the string was missing from the cottonoid sponge.The surgical team was immediately informed.The surgical area was inspected, as was the surrounding area.Suspecting the string had been suctioned into the neptune machine, the suction manifold was removed from the machine.The suction manifold filter had caught the string, and the string was then removed from the filter.Visual confirmation of the string was completed by circulator, ctl [care team leader], and fellow.Surgeon informed.The patty and string were obtained, placed in a biohazard bag, and taken to the front desk.

• Brand Name: MEDLINE
• Common Device Name: NEUROSURGICAL PADDIE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 23815609
• Report Number: 23815609
• Device Sequence Number: 9963643
• Product Code: HBA
• UDI-Device Identifier: 20080196286659
• UDI-Public: (01)20080196286659
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2025
• Report Date (Section F): 11/24/2025

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: NEUROSPNG05
• Device Catalogue Number: NEUROSPNG05
• Device Lot Number: 6052502005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2025
• 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
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 11/24/2025