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

Model Number A303316A

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 10/16/2021

Event Type  malfunction  

Event Description

Foley balloon not intact.Fda safety report id# (b)(4).

• Brand Name: BARD SURESTEP FOLEY TRAY SYSTEM
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC. ; covington GA 30014
• MDR Report Key: 12681625
• MDR Text Key: 278169692
• Report Number: MW5104843
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741073793
• UDI-Public: (01)00801741073793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: A303316A
• Device Catalogue Number: A303316A
• Device Lot Number: NGFV3833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR