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

Lot Number NGEZ0921

Device Problems Device Slipped (1584); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

Event Description

Foley placed at 1549 without complications.Shortly after placement patient got up to have a bowel movement.After sitting down patient stated he felt like he was urinating.While assessing foley, the tube came out and balloon was deflated.Upon inspection foley catheter had a tear.Patient denied pain.Upon inspection the balloon had a u shaped tear in it.No issues noted during insertion.

• Brand Name: SURESTEP FOLEY TRAY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 11677687
• MDR Text Key: 245821320
• Report Number: 11677687
• 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

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: NGEZ0921
• Was Device Available for Evaluation?: Yes
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA