MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TTL1LYR 16FR10ML 100%SILI DB TRA

Catalog Number	URO170716
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, the foley balloon "deflated" causing the "loss of chemo" and "chemo leakage onto patient".
Additional Manufacturer Narrative
According to the customer, the foley balloon "deflated" causing the "loss of chemo" and "chemo leakage onto patient".The customer did not report any serious injury, medical intervention, or follow up care needed related to the reported incident.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.
Additional Manufacturer Narrative
Update to h6: investigation conclusions.

• Common Device Name: TTL1LYR 16FR10ML 100%SILI DB TRA
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 18955758
• Report Number: 1417592-2024-00433
• Device Sequence Number: 9291336
• Product Code: OHR
• UDI-Device Identifier: 40888277866912
• UDI-Public: 40888277866912
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/23/2024

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: URO170716
• Device Lot Number: 23LBS157
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 07/23/2024
• 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 Sex: Unknown