MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® LUBRI-SIL® CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number	A942208
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
After a foley was placed, nursing noted later that night that the clear air port of the foley was leaking.The red seal was then removed and new tubing was attached.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® LUBRI-SIL® CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 1211 mary magnan blvd.; madison GA 30650
• MDR Report Key: 8023575
• Report Number: 8023575
• Device Sequence Number: 16486147
• Product Code: EZL
• UDI-Device Identifier: 00801741100550
• UDI-Public: (01)00801741100550
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/25/2018
• Report Date (Section F): 10/25/2018

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: A942208
• Device Catalogue Number: A942208
• Device Lot Number: NGCT2756
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2018
• 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: 10/25/2018