MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT PRECONNECTED DRAINAGE SYSTEM; CATHETER, RETENTION TYPE, BALLOON

Catalog Number 171100-000140

Device Problem Deflation Problem (1149)

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

Event Date 11/26/2022

Event Type  malfunction  

Event Description

It was reported that two similar incidents occurred with this device: the urine catheter was found in the bed of the patient, balloon fully deflated, for no apparent reason and there is no sign of breakage in the balloon or the catheter.

Manufacturer Narrative

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

Event Description

It was reported that two similar incidents occurred with this device: the urine catheter was found in the bed of the patient, balloon fully deflated, for no apparent reason and there is no sign of breakage in the balloon or the catheter.

Manufacturer Narrative

Qn#(b)(4).There was no complaint sample returned for investigation.Therefore, no physical assessment could be conducted, and investigation will be based on documentation review.Based on the complaint description, it was reported that the catheter was leaking.Catheter leak may happen due to in contact with sharp object or mishandling during catheterization.However, without actual or representative sample returned for investigation, the actual root cause of this phenomenon could not be determined.In current manufacturing process, the catheters are subjected to 100% water leak test after funnel molding process as per spm-a51-002.Catheter funnel and shaft will be immersed into water with continuous air flow to check for any leak or blockage.Any defects will be segregated before proceeding to next process.After completed assembled, per spm-a52-004 the catheters are then being inflated with air at 1.5 times the inflation volume and subjected to 100% inspection.All defective catheters will be culled out during this process.The balloons are then subjected to leak test for 20 minutes and upon completion of the test, will be subjected to deflation process and only products that passed all the tests will be shipped out.Catheter leak could be due to several reasons.However, in the absence of the returned sample, further investigation could not be conducted, and the actual root cause of this phenomenon could not be determined.Therefore, this complaint could not be confirmed.

• Brand Name: BRILLANT PRECONNECTED DRAINAGE SYSTEM
• 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: 16131967
• MDR Text Key: 308538817
• Report Number: 8040412-2023-00014
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 171100-000140
• Device Lot Number: KME22B0853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2023
• 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