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

Lot Number NGGX5309

Device Problems Inflation Problem (1310); Component Missing (2306)

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

Event Date 04/07/2023

Event Type  malfunction  

Event Description

Attempt to inflate balloon on foley.Noted balloon not working.Upon inspection, end piece missing.No harm to patient.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 16763230
• MDR Text Key: 313569079
• Report Number: MW5116746
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/13/2023

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 Lot Number: NGGX5309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Female