MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 1LYR TRY 14FR 10ML 100% SIL TMP SNAP

Catalog Number	URO175814TS
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, when the patient was repositioned on (b)(6) 2025 the foley catheter "fell out".The customer reported upon further review of the product there was a "hole in the balloon port".The customer reported an additional foley was inserted due to the reported incident.The customer did not report any serious injury related to the reported incident.No additional details are available related to the customer reported issue.No additional information is available at this time.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, when the patient was repositioned on (b)(6) 2025 the foley catheter "fell out".

• Common Device Name: 1LYR TRY 14FR 10ML 100% SIL TMP SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23341664
• Report Number: 1417592-2025-00562
• Device Sequence Number: 7771232
• Product Code: OHR
• UDI-Device Identifier: 10193489987539
• UDI-Public: 10193489987539
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 10/20/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: URO175814TS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/20/2025
• 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 Sex: Unknown