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

Catalog Number 170605-000140

Device Problem Break (1069)

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

Event Date 12/06/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (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 it happened in palliative care unit.The catheter was found cut in two at the level just before they hub on the side of the bladder.Consequence: discomfort for the patient.The device was changed; a new catheter was inserted.Happened with two different patients.Additional information: the catheters had been inserted no more than 24 hours before.The patients were not agitated.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed and no abnormalities found.There was no complaint sample returned for further investigation.Therefore, no physical assessment can be conducted.Due to there was no actual sample returned for investigation , therefore further investigation was not possible.Thus, this complaint could not be confirmed.

Event Description

It was reported that it happened in palliative care unit.The catheter was found cut in two at the level just before the y hub on the side of the bladder.Consequence: discomfort for the patient.The device was changed; a new catheter was inserted.Happened with two different patients.Additional information: the catheters had been inserted no more than 24 hours before.The patients were not agitated.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11046193
• MDR Text Key: 223606575
• Report Number: 8040412-2020-00275
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170605-000140
• Device Lot Number: 20EG16
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1