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

Catalog Number 170605-000220

Device Problem Deflation Problem (1149)

Patient Problems Pain (1994); Genital Bleeding (4507)

Event Date 05/26/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the removal of the catheter, i checked the emptiness of the balloon 3 times.The removal well started then the catheter remained blocked about 5 cm from the meatus.The patient was in pain, the catheter seemed to be blocked.The catheter was finally removed with great difficulty and it was observed that the balloon was still inflated with about 5 ml.The consequence was pain for the patient, stress for the nurse and an urethral bleeding at the end of the catheterization.Patient condition reported as fine.

Event Description

During the removal of the catheter, i checked the emptiness of the balloon 3 times.The removal well started then the catheter remained blocked about 5 cm from the meatus.The patient was in pain, the catheter seemed to be blocked.The catheter was finally removed with great difficulty and it was observed that the balloon was still inflated with about 5 ml.The consequence was pain for the patient, stress for the nurse and an urethral bleeding at the end of the catheterization.Patient condition reported as fine.

Manufacturer Narrative

Qn#(b)(4) the device lot number was not provided; therefore a dhr review could not be conducted.No alleged sample was returned for investigation.Hence, investigation was conducted based on document review.According to the description of the complaint, it could be conclude that the balloon was overinflated with more than 20ml of fluid.Overinflation may cause the collapse of lumen as well as lumen occlusion due to balloon asymmetry.Therefore this complaint could not be confirmed.

• 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: 14648661
• MDR Text Key: 300468163
• Report Number: 8040412-2022-00156
• 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
• Report Date: 05/30/2022

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: 170605-000220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 07/15/2022
• Supplement Dates FDA Received: 07/18/2022
• 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
• Treatment: N/A.