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

Device Problems Deflation Problem (1149); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

Patient had no urine output for two consecutive hours.Foley was found to be partially out of the patient with balloon deflated.New foley was inserted and urine coming out was frank blood.Rn tried to reinflate the old foley's balloon and it would not work.Unsure if balloon ruptured inside of patient.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 14102497
• MDR Text Key: 289189227
• Report Number: 14102497
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female