MAUDE Adverse Event Report: LSL INDUSTRIES, INC. PREMIUM URINARY DRAIN BAG WITH ANTI-REFLUX VALVE; URINE DRAIN BAG FOLEY / URINARY DRAINAGE COLLECTION KIT

Catalog Number 1450VA

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/10/2018

Event Type  malfunction  

Event Description

The bag itself is leaking around the creases and got urine all over an rn.

• Brand Name: PREMIUM URINARY DRAIN BAG WITH ANTI-REFLUX VALVE
• Type of Device: URINE DRAIN BAG FOLEY / URINARY DRAINAGE COLLECTION KIT
• Manufacturer (Section D): LSL INDUSTRIES, INC. ; chicago IL
• MDR Report Key: 8101681
• MDR Text Key: 128410160
• Report Number: MW5081571
• Device Sequence Number: 0
• Product Code: FCN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1450VA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1