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

Catalog Number 170605-000180

Device Problem Unintended Movement (3026)

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

Event Date 12/20/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported issue: incidents occurred in an elderly house.For one patient, two catheters self-expelled while the balloon was still inflated but there was no trauma, no bleeding for the female patient.It happened two days in a row.The balloon was inflated with 10 ml of sterile water.The female patient is paraplegic and requires catheterization.The balloon inflated with 10 ml of sterile water.The consequence was reported as no re-catheterization.

Manufacturer Narrative

Qn#(b)(4).No alleged sample was returned for investigation.Hence, investigation shall be conducted based on document review.The catheter self-expelled may be due to several potential factors such as leakage, asymmetrical balloon or balloon not sufficiently inflated.According to the product description, the balloon capacity recommended is 10ml.Catheter self-expelled with balloon inflated condition could also happen due to asymmetrical condition of the balloon.However, since no actual or representative sample returned, the asymmetry ratio could not be measured where the acceptable limit for balloon asymmetry is based on 1:3 per internal requirement of qas-a001.In the 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.Catheters with defective balloons will be culled out.There are several potential root causes that may cause the catheter to self-expelled with balloon in an inflated condition.However, without the presence of the physical sample, the root cause could not be identified.Therefore, this complaint could not be confirmed.

Event Description

Reported issue: incidents occurred in an elderly house.For one patient, two catheters self-expelled while the balloon was still inflated but there was no trauma, no bleeding for the female patient.It happened two days in a row.The balloon was inflated with 10 ml of sterile water.The female patient is paraplegic and requires catheterization.The balloon inflated with 10 ml of sterile water.The consequence was reported as no re-catheterization.

• 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: 16126839
• MDR Text Key: 308711539
• Report Number: 8040412-2023-00010
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170605-000180
• Device Lot Number: KME21F0307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2023
• 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
• Patient Sex: Female