MAUDE Adverse Event Report: C. R. BARD, INC. FOLEY BAG; CATHETER, RETENTION TYPE, BALLOON

Device Problems Fluid/Blood Leak (1250); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 08/14/2021

Event Type  malfunction  

Event Description

After emptying the foley bag, when closing the green circular latch, it would not seal completely.This caused urine to drip onto the floor.This staff rn noticed the puddle on the ground and cleaned it up before it became a slip hazard.The bag was exchanged for a new one.

• Brand Name: FOLEY BAG
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12778901
• MDR Text Key: 280533020
• Report Number: 12778901
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White