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

Catalog Number	URO175216
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423); Failure to Deflate (4060)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Genital Bleeding (4507)
Date of Event	11/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, patient had a foley catheter inserted on (b)(6) 2025, and on (b)(6) 2025, went to the er because the catheter was not "draining much" and was "leaking around the tip." rn and doctor attempted to drain the balloon, but it would not drain completely.
Additional Manufacturer Narrative
According to the facility, patient had a foley catheter inserted on (b)(6) 2025, and on (b)(6) 2025, went to the er because the catheter was not "draining much" and was "leaking around the tip." rn and doctor attempted to drain the balloon, but it would not drain completely.The pilot part of the balloon was cut off and still "did not drain.I used a blunt tip needle in the balloon opening, able to get 2 more ml out." doctor "thought that it should pull out with a smaller amount, so he did.The patient experienced bleeding and extreme pain during removal of the foley with the partially inflated balloon." a new catheter was placed.Patient is "feeling better." no additional information at this time.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.

• Brand Name: MEDLINE
• Common Device Name: 1LYRTR 16FR10ML LATEX UM SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23927868
• Report Number: 1417592-2025-00758
• Device Sequence Number: 13022034
• Product Code: OHR
• UDI-Device Identifier: 10193489987393
• UDI-Public: 10193489987393
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: URO175216
• Device Lot Number: 25DBS118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 109 KG