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

Catalog Number 170605-000120

Device Problems Defective Device (2588); No Flow (2991)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  malfunction  

Event Description

Catheter was placed during a supine surgery.The catheter was placed without any problems.The doctors noticed after some time that no urine was drained so the catheter was removed after 2 hours and a 3-lumen catheter was inserted.With the other catheter urine drained properly but a slight bleeding was noted which stopped soon.Additional information: the affected catheter was discarded.No patient injury occurred and there was no medical intervention required.The patient is fine.Lubricant used was instillagel, balloon was inflated with 10ml glycerine solution.

Manufacturer Narrative

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

Manufacturer Narrative

Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed all samples passed qa inspection.There was no complaint device returned for investigation.Therefore, no physical assessment could be conducted and an investigation was based on document review.Non-drainage could occur due to several reasons.However, in the absence of returned sample and limited information available in this complaint, further investigation is not able to be conducted.Therefore this complaint could not be confirmed.

Event Description

Catheter was placed during a supine surgery.The catheter was placed without any problems.The doctors noticed after some time that no urine was drained so the catheter was removed after 2 hours and a 3-lumen catheter was inserted.With the other catheter urine drained properly but a slight bleeding was noted which stopped soon.Additional information: the affected catheter was discarded.No patient injury occurred and there was no medical intervention required.The patient is fine.Lubricant used was instillagel, balloon was inflated with 10ml glycerine solution.

• 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: 12778890
• MDR Text Key: 281397975
• Report Number: 8040412-2021-00284
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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: 170605-000120
• Device Lot Number: 20BG03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/13/2021
• 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