MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL

Catalog Number 170605-000160

Device Problem Leak/Splash (1354)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 03/18/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.

Event Description

We had issues with these catheters: several sizes.Leakage of the balloon.Leaks appeared after 4-5 hours of use.Catheters self-expelled.Patients got irritation of the external urethral orifice.We had to re-catheterized the patients.No other medical intervention necessary.

Event Description

We had issues with these catheters: several sizes.Leakage of the balloon.Leaks appeared after 4-5 hours of use.Catheters self-expelled.Patients got irritation of the external urethral orifice.We had to re-catheterized the patients.No other medical intervention necessary.

Manufacturer Narrative

Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed all qa inspection.A representative sample was returned for investigation.Based on the complaint description, it was reported that balloon leak appeared after 4-5 hours of use.Investigation was initiated by inflating the catheters with 10ml of water.However, the balloon was able to stay inflated and no balloon burst or leak observed during the test.In current standard operating procedure, according to spm-a51-003 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, as per spm-a52-004 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.There was no abnormalities or design irregularities observed on the returned representative sample.The sample also can be inflated with no leak or burst balloon issue observed.Therefore, this complaint could not be confirmed.

Manufacturer Narrative

Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed all qa inspection.A representative sample was returned for investigation.Based on the complaint description, it was reported that balloon leak appeared after 4-5 hours of use.Investigation was initiated by inflating the catheters with 10ml of water.However, the balloon was able to stay inflated and no balloon burst or leak observed during the test.In current standard operating procedure, according to spm-a51-003 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, as per spm-a52-004 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.There was no abnormalities or design irregularities observed on the returned representative sample.The sample also can be inflated with no leak or burst balloon issue observed.Therefore, this complaint could not be confirmed.

Event Description

We had issues with these catheters: several sizes.Leakage of the balloon.Leaks appeared after 4-5 hours of use.Catheters self-expelled.Patients got irritation of the external urethral orifice.We had to re-catheterized the patients.No other medical intervention necessary.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13956447
• MDR Text Key: 298125790
• Report Number: 8040412-2022-00084
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2022

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: KME21H0457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 04/27/2022; 04/27/2022
• Supplement Dates FDA Received: 05/10/2022; 05/11/2022
• 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