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

Model Number A303416A

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2018

Event Type  malfunction  

Event Description

Patient reported leak from foley tube- tube noted to have pin hole in balloon port, with fluid stream leaking out and no saline in balloon.Foley removed.Licensed independent practitioner aware.Patient refused to replace foley, and was able to void without difficulty after removed.Discharged home.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7450232
• MDR Text Key: 106173042
• Report Number: 7450232
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741073823
• UDI-Public: (01)00801741073823
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2018

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
• Device Operator: No Information
• Device Expiration Date: 06/30/2020
• Device Model Number: A303416A
• Device Catalogue Number: A303416A
• Device Lot Number: NGCN1972
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1