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
Event or Problem Description
According to the facility s foley was placed and the balloon burst.
Additional Manufacturer Narrative
According to the facility a foley was placed and the balloon burst.The foley balloon was tested prior to insertion.There was no impact or serious injury according to the facility other than the foley being replaced.The device is not available for evaluation.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.The weight of the patient was not given by the facility, but 0 kg was entered in this mdr due to the submission portal not accepting the a4 field empty.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.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: 1LYR 14FR10ML 100%SIL TMP TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093 ; 2249317042
• MDR Report Key: 23880084
• Report Number: 1417592-2025-00734
• Device Sequence Number: 9464214
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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
• Device Catalogue Number: DYND160814T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/23/2025
• 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: 87 YR
• Patient Sex: Male