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.

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 they 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

Qn# (b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection.An actual sample and one piece of representative sample were returned for investigation.Based on the description, it was reported "when inserting the catheter on 5 days old newborn baby, the catheter bent when the guide was removed just below the y intersection".However, we could not understand the actual defect mode stated by the complainant.Visual inspection on both returned samples showed no obvious contamination, sign of damage, degradation or design abnormality.All features on the catheter appeared to be in good condition.Further investigation, the guide wire was slowly pulled out from the funnel.No issue was observed and both catheters were able to remain its original shape and form.Bent catheters may due to the position of the catheter in the pouch which might shift during handling or transportation process.However , this condition will not last as it will revert to its original shape after some time.This is because silicone catheter generally possessed flexibility properties, thus it will not appear stiffly rigid all the time.Based on the investigation conducted, it was found no abnormalities on both samples.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.

• Brand Name: BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9705795
• MDR Text Key: 183745861
• Report Number: 8040412-2020-00063
• 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

• Date FDA Received: 02/13/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1