MAUDE Adverse Event Report: C. R. BARD, INC. BARD SURESTEP FOLEY TRAY SYSTEM 16FR CATHETER; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number REF A300316A

Device Problems Inflation Problem (1310); Structural Problem (2506)

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

Event Type  malfunction  

Event Description

Upon checking foley prior to insertion it was noted the balloon did not inflate when the port was injected with sterile water.It was noted the port itself expanded (ballooned out) upon insertion.There was no patient involvement.Fda safety report id # (b)(4).

• Brand Name: BARD SURESTEP FOLEY TRAY SYSTEM 16FR CATHETER
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 11482572
• MDR Text Key: 240132586
• Report Number: MW5099983
• Device Sequence Number: 1
• Product Code: MJC
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF A300316A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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