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

Catalog Number 170605-000180

Device Problems Burst Container or Vessel (1074); Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The facility has communicated that the device is not available for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the patient ripped his catheter and the balloon burst and/or tore.The customer further stated that the patient pulled on the catheter with excessive force.

Event Description

It was reported that the patient ripped his catheter and the balloon burst and/or tore.The customer further stated that the patient pulled on the catheter with excessive force.

Manufacturer Narrative

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

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9660524
• MDR Text Key: 181823536
• Report Number: 8040412-2020-00029
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 170605-000180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1