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

Model Number URO170816

Device Problems Material Rupture (1546); Device Fell (4014)

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

Event Date 03/30/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility during a procedure the foley catheter balloon 'burst inside patient and fell out'.Per the facility after the catheter became dislodged an additional catheter needed to be placed.The sample was not available to be 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 Description

According to the facility during a procedure the foley catheter balloon 'burst inside patient and fell out'.

• Brand Name: Medline
• Type of Device: TTL1LYR 16FR10ML 100%SILI UM TRAY
• 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: 14168129
• MDR Text Key: 289758880
• Report Number: 1417592-2022-00056
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URO170816
• Device Catalogue Number: URO170816
• Device Lot Number: 21KBN881
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2022
• 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