MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY,FOLEY,CATH,SIL-ELAST,16FR,10ML,BG

Catalog Number	DYND11003
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the catheters are all leaking.".
Additional Manufacturer Narrative
Customer reported leaking foley catheter.Medline quality received 1 product in packaged, unused condition; visual assessment revealed no defects nor abnormalities, and functional testing inflated the foley balloon to 10ml without incident and the foley drained the full 300ml of simulated urine, with no leakage nor drainage issues observed.The reported issue could not be verified based on visual or functional inspection of the received samples, and no root cause was identified; possible root causes could include patient anatomy, catheter insertion procedure, bladder spasm, or an unobserved manufacturing defect.Due to the inability to confirm the complaint, as well as the low reported occurrence rate of this issue, no further corrective action is necessary at this time.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.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: TRAY,FOLEY,CATH,SIL-ELAST,16FR,10ML,BG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884246
• Report Number: 1417592-2026-49971
• Device Sequence Number: 13209443
• Product Code: OHR
• UDI-Device Identifier: 40080196991472
• UDI-Public: 40080196991472
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/23/2026

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: DYND11003
• Device Lot Number: 96922070002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/07/2023
• 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: 02/28/2023
• Initial Report FDA Received Date: 09/24/2026
• 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