MAUDE Adverse Event Report: Medline - Mexicali Medline; DBD-ENDOVASCULAR CDS

Catalog Number	CDS983394M
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the large towel in our endovascular cds this morning contained large pieces of lint.Medline notified and photos sent.There were no reports of death, serious injury, medical intervention, or follow up care.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
The large towel in our endovascular cds this morning contained large pieces of lint.

• Brand Name: Medline
• Common Device Name: DBD-ENDOVASCULAR CDS
• Manufacturer (Section D): Medline - Mexicali; calle circuito del desierto 71; baja california 21383 ; MX 21383
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50181005
• Report Number: 1423395-2026-00483
• Device Sequence Number: 8243232
• Product Code: OEZ
• UDI-Device Identifier: 10198459224508
• UDI-Public: 10198459224508
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: CDS983394M
• Device Lot Number: 26EMA813
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2026
• 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
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 212 LB
• Patient Race: White