MAUDE Adverse Event Report: COVIDIEN DOVER FOLEY CATHETER; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Lot Number 2029038

Device Problem Deflation Problem (1149)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2021

Event Type  Injury  

Event Description

Registered nurse was unable to deflate the balloon to remove the indwelling urinary catheter.Attending radiologist was called in and was also unsuccessful.Urology was contacted and were also unable to deflate the balloon.Urology used alternate method to puncture the balloon and deflate it in order to safely remove the patient's indwelling urinary catheter.Fda safety report id# (b)(4).

• Brand Name: DOVER FOLEY CATHETER
• Type of Device: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 12134875
• MDR Text Key: 260597256
• Report Number: MW5102339
• Device Sequence Number: 1
• Product Code: FCM
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2029038
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 MO
• Patient Weight: 12