MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 1LYR 14FR10ML 100%SIL TMP TRAY

Catalog Number	DYND160814T
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the foley balloon "burst" during insertion and required an additional foley to be placed.The customer reported the patient was on "comfort care" and is now "deceased".The customer did not report any information that would indicate that the product caused or contributed to the patient death.The patient was on "comfort care" prior to the incident occurring, which would indicate that the patient death is attributed to an issue unrelated to the product problem.The customer did not report any serious injury related to the reported product issue.No additional details are available related to the customer reported issue.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, the foley balloon "burst" during insertion and required an additional foley to be placed.

• Brand Name: MEDLINE
• Common Device Name: 1LYR 14FR10ML 100%SIL TMP TRAY
• 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: 23838451
• Report Number: 1417592-2025-00726
• Device Sequence Number: 13269476
• Product Code: OHR
• UDI-Device Identifier: 10884389123102
• UDI-Public: 10884389123102
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/18/2025

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: DYND160814T
• Device Lot Number: 25EBO645
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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: 87 YR
• Patient Sex: Male