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

Catalog Number 170605-000160

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2020

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 while inserted in the patient, there was a blockage of the catheter.The urine did not empty.It happened with several patients.For these patients we needed to call the urologist to have his opinion.Clinical consequences: the device needed to be removed and another one inserted.

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.Catheter blockage could be due to various reasons.However, in the absence of any actual or representative sample, further investigation could not be conducted to identify the actual root cause of the problem.Therefore, this complaint could not be confirmed.

Event Description

It was reported that while inserted in the patient, there was a blockage of the catheter.The urine did not empty.It happened with several patients.For these patients we needed to call the urologist to have his opinion.Clinical consequences: the device needed to be removed and another one inserted.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 10309904
• MDR Text Key: 201885674
• Report Number: 8040412-2020-00145
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

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: 170605-000160
• Device Lot Number: 19KG21
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.