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

Model Number URO170716

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 07/20/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2022.During the insertion of a foley catheter, after confirming placement, the foley catheter slipped out and required an additional catheter placement.Per the facility it was noted that balloon 'had ruptured'.The device is not available to be returned for evaluation.No additional information is available at this time.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 Description

According to the facility on (b)(6) 2022.During the insertion of a foley catheter, after confirming placement, the foley catheter slipped out and required an additional catheter placement.

• 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: 15405978
• MDR Text Key: 299758445
• Report Number: 1417592-2022-00161
• 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: 09/12/2022

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 Operator: Health Professional
• Device Model Number: URO170716
• Device Catalogue Number: URO170716H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/12/2022
• 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): Required Intervention