MAUDE Adverse Event Report: BARD/C.R. BARD, INC. BARD 2 WAY FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number 0000

Device Problems Difficult to Remove (1528); Improper Flow or Infusion (2954)

Patient Problem Laceration(s) (1946)

Event Date 12/14/2022

Event Type  Injury  

Event Description

Foley catheter was not draining properly.Unable to remove foley catheter and unable to drain bladder of balloon fill hole.Md to remove the following day.Patient was transferred for suprapubic catheter placement.Urologist reported previous foley "fell out" after suprapubic catheter was placed.Previous attempts were made to submit this report online.An error message was received that an error had occurred.The developers had been notified.

• Brand Name: BARD 2 WAY FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): BARD/C.R. BARD, INC.
• MDR Report Key: 16185913
• MDR Text Key: 307634981
• Report Number: MW5114343
• 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: 01/12/2023

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 Operator: Health Professional
• Device Model Number: 0000
• Device Catalogue Number: 0000
• Device Lot Number: 0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male