MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTL1LYR 16FR10ML 100%SILI UMST TR

Catalog Number	URO170816S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the customer received a catheter post-surgical (unknown procedure) and within 5 hours the catheter was falling out of the patient.The facility reported that the balloon was noted to be leaking so the catheter was removed.It is not facility protocol to pre-inflate the balloon of the catheter.There were no difficulties reported when the catheter was originally inserted.The facility replaced the catheter without further incident.There was no serious injury or follow-up medical care required related to the incident, however medical intervention to replace the foley catheter was necessary.The actual device that was involved in the incident has not been returned for evaluation.No additional information is available.Due to the reported incident and 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
It was reported that a foley catheter experienced a leak in the balloon and was removed from the patient.

• Common Device Name: TTL1LYR 16FR10ML 100%SILI UMST TR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8202399
• Report Number: 1417592-2018-00137
• Device Sequence Number: 16571628
• Product Code: OHR
• UDI-Device Identifier: 10889942126828
• UDI-Public: 10889942126828
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2018

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: URO170816S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR