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

Catalog Number 170605-000140

Device Problem Fluid/Blood Leak (1250)

Patient Problems Dysuria (2684); Insufficient Information (4580)

Event Date 12/01/2022

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: several incident have been observed in the oncology department in the past 2 month.The patients are complaining of urinary burns during the catheterization despite the foley being lubricated and leaks even after several changes in sizes with the balloon being deflated and reinflated.Patient condition is unknown.

Manufacturer Narrative

(b)(4).According to the complaint description, the device was shaving leakage.There was no complaint sample returned for investigation.Therefore, no physical assessment could be conducted, and investigation will be based on documentation review.Leakage of the catheter may happen due to several reasons such as being in contact with sharp object during use i.E.Contact with clamper, kidney dish/tray.In our current standard operating procedure ((b)(4)), the products are subjected to 100% visual inspection and any defective raw balloon will be culled out before sent to the next process.Upon completion of assembly process, the finished catheter will be again subjected to 100% balloon inspection and 20 minutes leak test.Catheter with defective balloon will be culled out during this process.In conclusion, due to no actual sample returned for this complaint, any further investigation was not possible.Therefore, this complaint could not be confirmed.

Event Description

Reported event: several incident have been observed in the oncology department in the past 2 month.The patients are complaining of urinary burns during the catheterization despite the foley being lubricated and leaks even after several changes in sizes with the balloon being deflated and reinflated.Patient condition is unknown.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• 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: 16373595
• MDR Text Key: 309581502
• Report Number: 8040412-2023-00038
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170605-000140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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