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

Model Number A303416A

Device Problems Deflation Problem (1149); Leak/Splash (1354); Device Dislodged or Dislocated (2923)

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

Event Date 08/25/2022

Event Type  malfunction  

Event Description

Foley catheter inserted and balloon inflated.Urine collected from foley with no problems.Foley slipped out when patient was putting her legs straight.Foley balloon tested and the balloon did not inflate at all.Saline squirted out of balloon.Had to reinsert a new foley catheter.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: 15321139
• MDR Text Key: 298984233
• Report Number: MW5111778
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• 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: 08/25/2022

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: A303416A
• Device Catalogue Number: A303416A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American