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

Catalog Number 170605-000140

Device Problem Inflation Problem (1310)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2022

Event Type  malfunction  

Manufacturer Narrative

(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: "involved a female patient 15 year-old, weight 40kg.Whilst removing the catheter, balloon was filled with 10 ml, the nurse did not manage to remove all the water.She removed 7 ml instead of 10ml.The nurse tried few times to re-inflate - re-deflate the balloon with no success.So the catheter was removed with a balloon slightly inflated.Which is painful for the patient.After removal it was observed that there was a little bit of water remaining in the balloon.The patient is fine now.

Manufacturer Narrative

(b)(4).The device lot number was not provided; therefore , a dhr review could not be conducted.Complaint verification testing could not be performed as no sample was returned for analysis.According to the description of the complaint, there were still remains in the balloon that could not be withdrawn.There are several potential root causes that may cause the non-inflation.However, without the presence of the physical sample, the root cause could not be identified.Therefore , this complaint could not be confirmed.

Event Description

It was reported that: " involved a female patient 15 year-old, weight 40kg.Whilst removing the catheter, balloon was filled with 10 ml, the nurse did not manage to remove all the water.She removed 7 ml instead of 10ml.The nurse tried few times to re-inflate - re-deflate the balloon with no success.So the catheter was removed with a balloon slightly inflated.Which is painful for the patient.After removal it was observed that there was a little bit of water remaining in the balloon.The patient is fine now.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15462613
• MDR Text Key: 301557590
• Report Number: 8040412-2022-00266
• 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: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170605-000140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2022
• 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.