MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. SELECT SILICONE FOLEY; CATHETER, RETENTION TYPE, BALLOON

Model Number UNKNOWN

Patient Problem Insufficient Information (4580)

Event Date 07/16/2023

Event Type  malfunction  

Event Description

Foley inserted in icu is leaking.Inaccurate urine output measurement due to leaking.

• Brand Name: SELECT SILICONE FOLEY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 17508946
• MDR Text Key: 320884312
• Report Number: 17508946
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN
• Device Lot Number: (10) 23ABT974
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1