MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 1LYR 16FR10ML 100%SILI C UM TRAY

Catalog Number	URO170816C
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Deflation (4061)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the patient's indwelling urinary catheter dislodged with the balloon deflated.Re-catheterization was required.According to the facility, the patient stated that the medline catheter was uncomfortable and "continued to fall out".The facility indicated that a catheter from a different vendor was placed afterward.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.
Event or Problem Description
It was reported that the patient's indwelling urinary catheter dislodged with the balloon deflated.Re-catheterization was required.According to the facility, the patient stated that the medline catheter was uncomfortable and "continued to fall out".The facility indicated that a catheter from a different vendor was placed afterward.
Additional Manufacturer Narrative
Update to d9, h3, and h6.After further investigation, it was determined that a sample was returned to the manufacturer on 1/7/26.The evaluation included testing of the actual/suspected device, a review of production records, and a trend analysis.The investigation identified a material problem, as longitudinal tears were present on both balloons, and the reported issue of balloon deflation was verified through visual assessment of the returned samples.A leakage/seal problem was identified.Functional testing was performed by attempting to inflate the balloons with 10 ml of water; the balloons were no longer functional and were unable to retain water, confirming the reported issue.However, despite the confirmed malfunction, the cause remains unestablished.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: 1LYR 16FR10ML 100%SILI C UM TRAY
• 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: 23984623
• Report Number: 1417592-2026-00010
• Device Sequence Number: 10704441
• Product Code: OHR
• UDI-Device Identifier: 10193489988727
• UDI-Public: 10193489988727
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/21/2026

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: URO170816C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/21/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 91 KG