MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX ALL-SILICONE FOLEY CATHETER 16FR; CATHETER, RETENTION TYPE, BALLOON

Model Number 165816

Device Problems Inflation Problem (1310); Material Rupture (1546); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/31/2021

Event Type  malfunction  

Event Description

Patient's urine output into foley catheter decreased.Catheter was visualized in urethra by rn and technician, bolus for low urine output was given.An hour later, patient complained of bladder feeling full with no output in the catheter bag.Upon inspection of catheter by technician, it was discovered that the catheter had come out of the bladder.The balloon was deflated and catheter slid out without trauma to patient.Patient was able to void.Rn tested catheter balloon and found that after re-inflation it slowly lost air until no longer inflated.Catheter information: bardex 16fr.165816.Ngev4767.

• Brand Name: BARDEX ALL-SILICONE FOLEY CATHETER 16FR
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12532102
• MDR Text Key: 273371621
• Report Number: 12532102
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Device Lot Number: NGEV4767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1