MAUDE Adverse Event Report: MEDLINE - MEXICALI MEDLINE; DBD-VASCULAR CDS-LF

Catalog Number	CDS983390L
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: DBD-VASCULAR CDS-LF
• Manufacturer (Section D): MEDLINE - MEXICALI; calle circuito del desierto 71; baja california 21383 ; MX 21383
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25816039
• Report Number: 1423395-2026-00385
• Device Sequence Number: 20346549
• Product Code: OEZ
• UDI-Device Identifier: 10198459224515
• UDI-Public: 10198459224515
• 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): 07/14/2026

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: CDS983390L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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