MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number A303316A

Patient Problem Insufficient Information (4580)

Event Date 03/26/2024

Event Type  malfunction  

Event Description

Rn tested inflation balloon prior to insertion of foley into patient.Balloon would not deflate, took effort to reposition syringe to get balloon to deflate.Foley not used and saved for investigation.

• Brand Name: SURESTEP
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 19151965
• MDR Text Key: 340694446
• Report Number: 19151965
• Device Sequence Number: 1
• Product Code: MJC
• 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: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A303316A
• Device Catalogue Number: A303316A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1