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

Catalog Number URO170716

Device Problem Deflation Problem (1149)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/22/2024

Event Type  Injury  

Event Description

According to the customer, the foley balloon "deflated" causing the "loss of chemo" and "chemo leakage onto patient".

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.

• Type of Device: TTL1LYR 16FR10ML 100%SILI DB TRA
• 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: 18955758
• MDR Text Key: 338305292
• Report Number: 1417592-2024-00433
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 40888277866912
• UDI-Public: 40888277866912
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: URO170716
• Device Lot Number: 23LBS157
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other