MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC

Catalog Number 170003-000060

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2020

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 when inserting the catheter on (b)(6) days old newborn baby, the catheter bent when the guide was removed just below the y intersection.The incident happened twice on different devices from same lot.Clinical consequences: risk of lesion.Device removed and new one inserted.Further information indicates no patient injury.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection.There is no returned sample for investigation, thus the investigation was primarily focused on document history review.However, with the absent of sample, actual condition of the catheter is unable to be determined.Bent catheters condition will not last as it will revert to its original shape after some time due to its flexibility properties.Therefore, this complaint could not be confirmed.

Event Description

It was reported that when inserting the catheter on 5 days old newborn baby, the catheter bent when the guide was removed just below the y intersection.The incident happened twice on different devices from same lot.Clinical consequences: risk of lesion.Device removed and new one inserted.Further information indicates no patient injury.

• Brand Name: BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9705779
• MDR Text Key: 183742810
• Report Number: 8040412-2020-00060
• 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: 01/31/2020

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: 04/28/2024
• Device Catalogue Number: 170003-000060
• Device Lot Number: 19EE22
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1