MAUDE Adverse Event Report: C.R. BARD, INC. SURESTEP FOLEY TRAY SYSTEM BARDEX ALL- SILICONE FOLEY CATHETER TRAY; CATHETER, RETENTION TYPE, BALLOON

Model Number A902416

Patient Problem Chemical Exposure (2570)

Event Date 11/27/2023

Event Type  malfunction  

Event Description

Foley placed and urine returned to the urometer.Foley clamped and chemotherapy instilled.Patient tolerated and chemo/urine returned to the urometer.Foley pulled without incident.On the way to the bathroom, urometer was tipped to go into the collection bag and began leaking from the back of the foley bag, leaving a trail of chemo/urine to the toilet.Upon inspection, there appeared to be a torn hole in the back of the bag about the size of a pea.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM BARDEX ALL- SILICONE FOLEY CATHETER TRAY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 19115109
• MDR Text Key: 340266818
• Report Number: 19115109
• 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: 12/08/2023

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 Model Number: A902416
• Device Catalogue Number: A902416
• Device Lot Number: NGHW0609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/16/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female