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

Catalog Number 170605-000160

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/30/2020

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

Reported issue: the foley was found leaking.

Manufacturer Narrative

Qn# (b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed 100% inspection.There was no complaint device returned for investigation.Only photo was provided.Therefore, no physical assessment could be conducted on the production samples.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

Reported issue: the foley was found leaking.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 10986255
• MDR Text Key: 221485902
• Report Number: 8040412-2020-00267
• 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: 12/03/2020

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 Expiration Date: 05/31/2020
• Device Catalogue Number: 170605-000160
• Device Lot Number: 15FE23
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1