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

Catalog Number 170605-000140

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

Event Description

Reported issue: on several catheters and patients it was noted that after 1-2 days of usage urine leaked along the catheter shaft.The balloon of the devices is being inflated with 10 ml sterile water.The exact quantity of defective devices and number of patients is unknown.In most cases the catheter was replaced.Patients were not harmed.Further event details are not available.The exact quantity of defective devices remains unknown.

Manufacturer Narrative

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

Manufacturer Narrative

Qn#(b)(4).Leaking may happen due to several reasons such as being in contact with sharp object during use, mis-positioning of the catheter, balloon leaking or bursting etc.The leaking is not being described clearly especially the leaking point is not able to be identified without the returned of the actual sample for physical assessment.In our current standard operating procedure, 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, since no actual sample returned for this investigation, any further investigation was not possible.Therefore, this complaint could not be confirmed.

Event Description

Reported issue: on several catheters and patients it was noted that after 1-2 days of usage urine leaked along the catheter shaft.The balloon of the devices is being inflated with 10 ml sterile water.The exact quantity of defective devices and number of patients is unknown.In most cases the catheter was replaced.Patients were not harmed.Further event details are not available.The exact quantity of defective devices remains 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: 16462138
• MDR Text Key: 310523653
• Report Number: 8040412-2023-00055
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

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 Catalogue Number: 170605-000140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 03/24/2023
• 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