MAUDE Adverse Event Report: C.R. BARD, INC. BARD FOLEY; CATHETER, COUDE

Model Number 16FR TEMP SENSING

Device Problems Defective Device (2588); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 02/21/2021

Event Type  Injury  

Event Description

Foley catheter defective; pt admitted on (b)(6) 2021.Foley inserted (b)(6) at 0700, at (b)(6) sampling port found lying in the bed.Fda safety report id# (b)(4).

• Brand Name: BARD FOLEY
• Type of Device: CATHETER, COUDE
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 11404171
• MDR Text Key: 234677596
• Report Number: MW5099734
• Device Sequence Number: 1
• Product Code: EZC
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16FR TEMP SENSING
• Was Device Available for Evaluation?: No
• 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