MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-METER,URINE,400ML,DRAIN BAG,L/F,LL,S

Catalog Number	DYND27403SH
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: DBD-METER,URINE,400ML,DRAIN BAG,L/F,LL,S
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: felipe bifareti
• MDR Report Key: 50716190
• Report Number: 1417592-2026-35903
• Device Sequence Number: 10057126
• Product Code: FFG
• UDI-Device Identifier: 10080196749577
• UDI-Public: 10080196749577
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/06/2026

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: DYND27403SH
• Device Lot Number: 0332410A018
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2025
• 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: 04/21/2025
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown