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

Model Number FOLEY MFG #A3199416AM

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2021

Event Type  Injury  

Event Description

Port to irrigate/draw urine of foley catheter broke off.Occurred as syringe was placed in port.Foley was clamped and immediately removed to prevent infection.Foley and port connected to syringe saved and placed in biohazard bag.Reported to supply manger.Foley mfg #: a3199416am.Fda safety report id# (b)(4).

• Brand Name: FOLEY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 11348969
• MDR Text Key: 232871108
• Report Number: MW5099501
• Device Sequence Number: 1
• Product Code: EZL
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FOLEY MFG #A3199416AM
• 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