MAUDE Adverse Event Report: FOLEY 24 FR CATHETER; CATHETER, RETENTION TYPE, BALLOON

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/21/2022

Event Type  Injury  

Event Description

Pt arrived to the ed for placement of a urinary catheter d/t hematuria.Catheter was inserted until urinary return and balloon was inflated with 10cc of saline, when going to inflate balloon further, unable to do so, also unable to deflate balloon and replace catheter.Per urology catheter was cut at port which did not drain the balloon.Patient was transferred to another hospital for urology consult.A stiff wire was to pop the balloon without success.The balloon could be felt in the perineum and a 20 g needle was used to pierce the balloon through the perineum.A 22fr 3 way hematuria catheter was inserted and inflated.Fda safety report id # (b)(4).

• Brand Name: FOLEY 24 FR CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• MDR Report Key: 13592616
• MDR Text Key: 286226721
• Report Number: MW5107694
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/21/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White