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

Device Problems Fluid/Blood Leak (1250); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2021

Event Type  malfunction  

Event Description

The twist-sampling port on the foley bag was leaking and fell off the bag after the foley was placed.Urine spilled out of the port due to this malfunction.

• Brand Name: BARD 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: 12323888
• MDR Text Key: 266694709
• Report Number: 12323888
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 07/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Weight: 114