MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP FOLEY TRAY SYSTEM LUBRI-SIL IC COMPLETE CARE; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number A319516AM

Device Problems Flushing Problem (1252); No Flow (2991)

Patient Problem Urinary Retention (2119)

Event Date 11/24/2020

Event Type  malfunction  

Event Description

Foley catheter placed in ed.There was no drainage from the foley, patient¿s bladder scan was >999ml.Positioning verified with 2nd rn, attempted to flush foley and was unable.Foley changed, greater than 1.2 lt urine out.Visual inspection of catheter showed nothing unusual.Once the foley was removed an attempt was made to use the flush port forcefully and it was unable to be flushed.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM LUBRI-SIL IC COMPLETE CARE
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 11093595
• MDR Text Key: 224254610
• Report Number: 11093595
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A319516AM
• Device Catalogue Number: A319516AM
• 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: 12/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20236 DA