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

Device Problem Material Deformation (2976)

Patient Problem Pain (1994)

Event Date 03/05/2019

Event Type  malfunction  

Event Description

Foley was removed with force and tip inspected.The balloon rolled in itself to create a donut around the tip.The balloon was re-inflated to ensure it had not torn while inside the patient.The balloon was verified to be intact.The position of the balloon when it was in the patient it had rolled up to cause a donut which created a larger and larger diameter as it came to the end of the urethra.This potential is a product failure and causing unnecessary pain to patient.Dates of use: 5 hours.

• Brand Name: BARD FOLEY CATHETER TRAY
• Type of Device: CATHETER CARE TRAY
• Manufacturer (Section D): C.R.BARD, INC
• MDR Report Key: 8403437
• MDR Text Key: 138274154
• Report Number: MW5084748
• Device Sequence Number: 1
• Product Code: OHR
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR