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

Catalog Number 170605-000160

Device Problem Fluid/Blood Leak (1250)

Patient Problem Swelling/ Edema (4577)

Event Date 01/03/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending and a follow-up report will be issued after the investigation is completed.Teleflex will continue to monitor and trend related events.

Event Description

Reported event: the catheters inserted leaked and needed to re-inflate the balloon several times.No reported injury.

Event Description

Reported event: the catheters inserted leaked and needed to re-inflate the balloon several times.No reported injury.

Manufacturer Narrative

(b)(4).An actual sample was returned for investigation.It was reported that balloon deflated.Balloon needed to re-inflate several times a week.Visual examination was performed on the returned sample and no material degradation or abnormalities observed.The entire components appeared to be in good condition.The catheter then inflated with 10ml of red color water.The balloon inflated normally and no difficulties during inflation.The sample then deflated using an empty syringe without any problem arise.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.The returned sample did not exhibit any failure of balloon leak.Based on the investigation conducted, the balloon was still able to retain its inflated condition.Therefore, this complaint could not be confirmed as stated.

• 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: 16244618
• MDR Text Key: 308358891
• Report Number: 8040412-2023-00008
• 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: 01/03/2023

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: 170605-000160
• Device Lot Number: KME22J0838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 02/24/2023
• 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