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

Model Number	URO170716
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the patient had a foley inserted on (b)(6) 2023 and "3 hours later" the balloon had "popped" causing "blood where the balloon would have been".The customer reported an additional catheter was placed and the balloon was found with a "longitudinal split".According to the customer the patient denies any "pulling/trauma".No additional information is available at this time.The sample was requested for evaluation.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
According to the customer, the patient had a foley inserted on (b)(6) 2023 and "3 hours later" the balloon had "popped" causing "blood where the balloon would have been".

• Brand Name: Medline
• Common Device Name: TTL1LYR 16FR10ML 100%SILI DB TRA
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17208637
• Report Number: 1417592-2023-00264
• Device Sequence Number: 12147673
• Product Code: OHR
• UDI-Device Identifier: 10888277866911
• UDI-Public: 10888277866911
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/27/2023

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 Model Number: URO170716
• Device Catalogue Number: URO170716
• Device Lot Number: 22LBS777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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