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

Model Number A902416

Device Problem Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/09/2022

Event Type  malfunction  

Event Description

A (b)(6) male admitted with hyponatremia and urinary retention.Bladder scan showed 700cc urine.Patient had a foley cath inserted for intermittent catheterization.750cc urine emptied from the bladder.The nurse deflated the balloon and attempted to remove the catheter.The nurse reported the catheter was stuck in the penis and she was not able to remove the catheter.She contacted the physician who called a urologist.The urologist was able to remove the catheter.The balloon was completely deflated.Unsure why the catheter was not able to be removed.The urologist inserted an indwelling coude foley catheter.Fda safety report id # (b)(4).

• Brand Name: BARD SURE STEP FOLEY TRAY SYSTEM
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 14160287
• MDR Text Key: 289775895
• Report Number: MW5109152
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A902416
• Device Catalogue Number: A902416
• Device Lot Number: NGGN1121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White