MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TTL1LYR 16FR10ML 100%SILI UM TRAY

Catalog Number URO170816

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2024

Event Type  Injury  

Manufacturer Narrative

It was reported that the foley balloon ruptured during chemotherapy.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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

Foley balloon ruptured while in patient.

• Type of Device: TTL1LYR 16FR10ML 100%SILI UM TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18970650
• MDR Text Key: 338508902
• Report Number: 1417592-2024-00440
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10888277862623
• UDI-Public: 10888277862623
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: URO170816
• Device Lot Number: 23JBV107
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2024
• 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