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

Catalog Number 170605-000140

Device Problem Deflation Problem (1149)

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

Event Date 12/23/2021

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

Female patient was catheterized before a c-section.The balloon was inflated with success.During the wash of the patient it was observed the catheter had self-expelled.When we checked the balloon once out of the patient we observed the balloon is inflating properly but then self-deflates.The device was not tested before use.Clinical consequence: no consequence for the patient.She was not re-catheterized.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed all samples passed qa inspection.There was no complaint sample returned for investigation.Therefore, no physical assessment could be conducted, and investigation will be based on documentation review.Due to no actual sample returned for this complaint, any further investigation was not possible.Moreover, simulation test has been carried out based on representative sample from production, there is no abnormality found.Therefore, this complaint could not be confirmed.

Event Description

Female patient was catheterized before a c-section.The balloon was inflated with success.During the wash of the patient it was observed the catheter had self-expelled.When we checked the balloon once out of the patient we observed the balloon is inflating properly but then self-deflates.The device was not tested before use.Clinical consequence: no consequence for the patient.She was not re-catheterized.

• 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: 13098443
• MDR Text Key: 285233043
• Report Number: 8040412-2021-00346
• 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: 12/24/2021

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: 170605-000140
• Device Lot Number: KME21F2217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 02/08/2022
• 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