MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC; CATHETER, RETENTION TYPE, BALLOON

Catalog Number 170003-000080

Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A few minutes after insertion urine leaked out of the catheter shaft near the funnel-shaft junction.No tension force was applied on the catheter.The same issue occurred approximately 4 times in the last 3 months.The lot number of these catheters is unknown.On (b)(6) 2022 another catheter of lot kme21g1883 was checked visually and a small hole was noted near the funnel.The used catheter was disposed but the unused catheter will be returned for investigation.

Manufacturer Narrative

Qn#(b)(4).The device lot number was not provided; therefore a dhr review could not be conducted.There was no complaint device returned for investigation.In the absence of any actual or representative sample for investigation, further investigation could not be conducted to identify the actual root cause of this reported failure.Therefore, this complaint could not be confirmed.

Event Description

A few minutes after insertion urine leaked out of the catheter shaft near the funnel-shaft junction.No tension force was applied on the catheter.The same issue occurred approximately 4 times in the last 3 months.The lot number of these catheters is unknown.On 07-jul-2022 another catheter of lot kme21g1883 was checked visually and a small hole was noted near the funnel.The used catheter was disposed but the unused catheter will be returned for investigation.

• Brand Name: BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
• 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: 15103254
• MDR Text Key: 303149910
• Report Number: 8040412-2022-00213
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/12/2022

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: 170003-000080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 09/01/2022
• 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