MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® I.C. COMPLETE CARE FOLEY CATHETER; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number	A319414AM
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	11/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Four bard foley's leaking from seal near reflux port.All foley's had to be replaced with new foleys causing an increased risk for catheter associated urinary tract infection for each patient and an increased cost.At this time it is not know if any of these patients experienced an infection due to the additional foley insertion required following these leaking devices.Manufacturer response for catheter, urological (antimicrobial) and accessories, surestep¿ foley tray system bardex® i.C.Complete care foley catheter (per site reporter).Manufacturer response for catheter, urological (antimicrobial) and accessories, surestep¿ foley tray system bardex® i.C.Complete care foley catheter (per site reporter).Manufacturer will be sending boxed to this facility to ship back for investigation.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® I.C. COMPLETE CARE FOLEY CATHETER
• Common Device Name: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 8119666
• Report Number: 8119666
• Device Sequence Number: 18882568
• Product Code: MJC
• UDI-Device Identifier: 00801741073854
• UDI-Public: (01)00801741073854
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2018
• Report Date (Section F): 11/13/2018

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
• Operator of Device: No Information
• Device Model Number: A319414AM
• Device Catalogue Number: A319414AM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/13/2018