MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, TIEMANN; CATHETER, RETENTION TYPE, BALLOON

Catalog Number 171305-000200

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Reported event: the department complained of leaks from the urinary meatus of the patient.The origin of the leak is unknown.The nurses have attempted inflation and deflation without change in leaks.There was no reported injury.The total event reported is ten.

Manufacturer Narrative

Qn#(b)(4).One pieces actual sample return for investigation, based on the complaint description there is important leak from the urinary meatus while catheter is still in patient.It was stated the user was an elderly patient over 70 years old and the need for catheterization was due to full bladder or deterioration general state required indwelling catheter.In the photograph provided the catheter shaft was inspected with 30x magnification lens, and no kinks or deformation observed.The balloon then inflated to with 10ml distilled water and does not show any abnormal that can cause poor catheterization positioning.However, there was significant encrustation or sediment along from the drainage eye until the catheter drainage funnel.This can prompt into blockage of catheter due to reduction in drainage diameter.Hence this had caused the urine is by passing the catheter and leak through urinary meatus.Encrustation and sediment build up inside the drainage lumen.Based on the investigation, the urine leaking outside the catheter was due to encrustation or sediment build up that restricting the free flow of the urine along the catheter drainage lumen; hence this complaint cannot be confirmed.

Event Description

Reported event: the department complained of leaks from the urinary meatus of the patient.The origin of the leak is unknown.The nurses have attempted inflation and deflation without change in leaks.There was no reported injury.The total event reported is ten (10).

• Brand Name: BRILLANT 2-W SILICONE FOLEY, TIEMANN
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16246775
• MDR Text Key: 308646135
• Report Number: 8040412-2023-00026
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 171305-000200
• Device Lot Number: KME22H2734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED