MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 1LYRTR 16FR10ML LATEX DB SNAP

Catalog Number	URO175116
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, the patient was transferred to the transplant unit on (b)(6) 2026 with a medline foley catheter in place, which was noted to be draining appropriately.The reporter observed the patient on (b)(6) 2026 with the medline foley continuing to drain without difficulty.On (b)(6), the foley collection bag was noted to have no urine output.A bladder scan performed by nursing staff showed approximately 400 ml in the bladder.The nurse removed the medline foley catheter using a slow, rotating motion, and no urine drained during removal.Upon inspection of the removed catheter, the reporter documented that there were no kinks, no sediment, and the eyelets were open.A bard coude foley catheter was then inserted by nursing staff, and approximately 400 ml drained immediately.The bard foley continued to drain appropriately thereafter.The patient had preexisting conditions and had been using foley catheters intermittently post surgery due to these issues.Increased abdominal pressure was present prior to foley use and was attributed to other conditions.
Additional Manufacturer Narrative
According to the facility, the patient was transferred to the transplant unit on (b)(6) 2026 with a medline foley catheter in place, which was noted to be draining appropriately.The reporter observed the patient on (b)(6) 2026 with the medline foley continuing to drain without difficulty.On (b)(6) 2026, the foley collection bag was noted to have no urine output.A bladder scan performed by nursing staff showed approximately 400 ml in the bladder.The nurse removed the medline foley catheter using a slow, rotating motion, and no urine drained during removal.Upon inspection of the removed catheter, the reporter documented that there were no kinks, no sediment, and the eyelets were open.A bard coude foley catheter was then inserted by nursing staff, and approximately 400 ml drained immediately.The bard foley continued to drain appropriately thereafter.The patient had preexisting conditions and had been using foley catheters intermittently post surgery due to these issues.Increased abdominal pressure was present prior to foley use and was attributed to other conditions.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Update to h6.After further investigation, it has been determined that the investigation involved testing of the actual/suspected device and trend analysis.No device problem was found or detected.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: 1LYRTR 16FR10ML LATEX DB SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24214717
• Report Number: 1417592-2026-00074
• Device Sequence Number: 8197191
• Product Code: OHR
• UDI-Device Identifier: 10193489987294
• UDI-Public: 10193489987294
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: URO175116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/20/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 45 KG