MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - WAUKEGAN MEDLINE; DBD-CYSTO PACK

Catalog Number	DYNJ44862N
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that there was pilling of timeout towel.Concerned for potential retained fragments in surgical case.Product provided by staff to manager.There were no reports of death, serious injury, medical intervention, or follow up care.
Event or Problem Description
Towel is linting.

• Brand Name: MEDLINE
• Common Device Name: DBD-CYSTO PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - WAUKEGAN; 1170 s northpoint blvd; waukegan IL 60085 6757
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25075841
• Report Number: 1423395-2026-00125
• Device Sequence Number: 10357835
• Product Code: FDE
• UDI-Device Identifier: 10198459049392
• UDI-Public: 10198459049392
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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 Catalogue Number: DYNJ44862N
• Device Lot Number: 25LDB178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2025
• 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 Sex: Unknown