MAUDE Adverse Event Report: C.R. BARD INC. SURESTEP FOLEY TRAY SYSTEM 16FR URINARY CATHETER; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number A343416A

Device Problem Deflation Problem (1149)

Patient Problem Insufficient Information (4580)

Event Date 06/22/2022

Event Type  malfunction  

Event Description

Sure step foley 16 fr lubri-sil ic catheter balloon unable to be deflated.Surgeon attempted to deflate by cutting inflation/deflation port with no change.Surgeon ultimately utilized a 21g needle to puncture/aspirate balloon with success.Fda safety report id # (b)(4).

• Brand Name: SURESTEP FOLEY TRAY SYSTEM 16FR URINARY CATHETER
• Type of Device: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): C.R. BARD INC.; covington GA 30014
• MDR Report Key: 14829879
• MDR Text Key: 294941320
• Report Number: MW5110516
• Device Sequence Number: 1
• Product Code: FCM
• 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: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• 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: 49 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic