MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRAPE,FEMORAL ANGIOGRAPHY,W/POUCH,8/CS

Catalog Number	DYNJP4119
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: DRAPE,FEMORAL ANGIOGRAPHY,W/POUCH,8/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50809408
• Report Number: 1417592-2026-44223
• Device Sequence Number: 21485496
• Product Code: PUI
• UDI-Device Identifier: 10080196283248
• UDI-Public: 10080196283248
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/17/2026

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: DYNJP4119
• Device Lot Number: 30525030123
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/10/2025
• 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: 10/03/2025
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown