MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP FOLEY TRAY SYSTEM; CATHETER, RETENTION TYPE, BALLOON

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2021

Event Type  malfunction  

Event Description

This rn at bedside to clean-up patient post-op.Upon completing foley catheter care, rn noted chux to be saturated with "clear fluid", and bed sheet appeared to be saturated as well.Upon further inspection, pt's foley catheter was disconnected at the point of connection between the foley tube, and drainage bag tubing (the part that is protected with a red, plastic sheath).

• Brand Name: SURESTEP FOLEY TRAY SYSTEM
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 11677696
• MDR Text Key: 245766555
• Report Number: 11677696
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/29/2021

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11315 DA
• Patient Weight: 118