MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY 24 FR 5CC BALLOONFOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number 0165V24S

Patient Problem Insufficient Information (4580)

Event Date 04/21/2024

Event Type  Injury  

Event Description

Patient arrived in er, foley just fell out this morning.Patient had urology surgery last week, (b)(6) 2024, went home with a foley.Urologist requested a replacement foley.Er nurse noticed the foley that wife brought from home did not have the tip intact.Palpated the penis, and all could feel the catheter within the urethra.Pa gently worked to broken catheter to where it was visualized and removed without complications.New intact foley was inserted without complications.

• Brand Name: 24 FR 5CC BALLOONFOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 19207158
• MDR Text Key: 341483231
• Report Number: MW5154389
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/24/2024

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: 0165V24S
• Device Catalogue Number: 0165V24S
• Device Lot Number: NGFN2779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention