MAUDE Adverse Event Report: Medline Industries LP Medline; ARTERIOGRAM PACK 2

Catalog Number	DYNJ83051A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: ARTERIOGRAM PACK 2
• Manufacturer (Section D): Medline Industries LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: michael crook ; three lakes dr; northfield, IL 60093
• MDR Report Key: 50917557
• Report Number: 1417592-2026-52334
• Device Sequence Number: 5393642
• Product Code: OES
• UDI-Device Identifier: 10195327452353
• UDI-Public: 10195327452353
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Device Catalogue Number: DYNJ83051A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown