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

Device Problems Break (1069); Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/02/2021

Event Type  Injury  

Event Description

The patient's foley bag was attached to the hospital bed and patient proceeded to walk across the room.The foley remained in the urethra and snapped, due to suspected tension.The tip of the foley recoiled in the patient.Fda safety report id# (b)(4).

• Brand Name: BD BARD FOLEY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): BD / C. R. BARD, INC.
• MDR Report Key: 12820484
• MDR Text Key: 280880890
• Report Number: MW5105343
• 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: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White