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

Model Number A343416A

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 09/26/2022

Event Type  malfunction  

Event Description

When urinary catheter was removed, the junction of the catheter and balloon was deformed and had a raised circumferential band present.Fda safety report id# (b)(4).

• Brand Name: SURESTEP FOLEY TRAY SYSTEM URINARY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD INC.; covington GA 30014
• MDR Report Key: 15515578
• MDR Text Key: 301043625
• Report Number: MW5112338
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A343416A
• Device Catalogue Number: A343416A
• Device Lot Number: PK7645887
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White