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

Model Number URO170716

Device Problem Material Integrity Problem (2978)

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

Event Date 05/13/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 317942560
• Report Number: 1417592-2023-00264
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10888277866911
• UDI-Public: 10888277866911
• 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: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• 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
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other