MAUDE Adverse Event Report: C.R BARD BARDEX FOLEY CATHETER; 3-WAY FOLEY CATHETER

Catalog Number 6003L22

Device Problems Material Deformation (2976); No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2016

Event Type  Injury  

Event Description

Catheter placed in bladder of patient.When attempted to irrigate the fluid would flow into the bladder, but could not get fluid to return.Attempted to flush catheter but could not get fluid through.Catheter removed and discovered that there was only one opening in the catheter.

• Brand Name: BARDEX FOLEY CATHETER
• Type of Device: 3-WAY FOLEY CATHETER
• Manufacturer (Section D): C.R BARD; covington GA 30014
• MDR Report Key: 5466421
• MDR Text Key: 39311710
• Report Number: MW5060563
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 6003L22
• Device Lot Number: NGZG3257
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 75