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

Model Number REF#A300416A

Device Problems Difficult to Remove (1528); Structural Problem (2506)

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

Event Date 02/02/2021

Event Type  malfunction  

Event Description

Urinary catheter was difficult to discontinue.The balloon was emptied completely prior to removal attempt, but resistance was noted to be present.Tube was advanced further and balloon rechecked to make sure all fluids were removed from balloon.There was noted to be a small ridge of silicone at the distal end of the catheter balloon, which is normally not present.Fda safety report id # (b)(4).

• Brand Name: BARD SURESTEP FOLEY TRAY SYSTEM
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC. ; covington GA 30014
• MDR Report Key: 11321390
• MDR Text Key: 232189922
• Report Number: MW5099357
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/09/2021

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: Health Professional
• Device Model Number: REF#A300416A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR