MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 270.04

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 09/30/2018

Event Type  Injury  

Manufacturer Narrative

The malfunctioning device will be returned to vygon for evaluation as part of the complaint investigation.The user wrote that it could be a device quality defect or an event not related to the devices.The batch review shows that it complies to its specifications.All these umbilical catheters are 100% tested for non-obstruction during the manufacturing process.Furthermore, the retained sample has been checked, it is compliant.No catheter obstruction were noticed.We have also checked our complaint's history, these are the first complaints on this batch.

Event Description

After 20 hours, it rings obstruction.The umbilical catheter has been withdrawn and replaced by a veinous catheter.

Event Description

After 20 hours, it rings obstruction.The umbilical catheter has been withdrawn and replaced by a veinous catheter.

Manufacturer Narrative

We received both samples for investigation, one umbilical catheter and one umbilical catheter connected to an extension line: blood was in one catheter, it was eliminated for testing.We performed an air non obstruction test in water, with both cathter we noticed air bubble.Then, a flush test with a solution was done,with both catheter we can noticed the flow of solution.The catheters are not obstructed.Furthermore, we recommend in the ifu to flush the catheter before and after each use with saline solution.These events are not due to a device defect.The alarm seems not related to a device defect.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen, 95440 ; FR 95440
• MDR Report Key: 8011123
• MDR Text Key: 125275960
• Report Number: 2245270-2018-00074
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• PMA/PMN Number: K921352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

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: No Information
• Device Model Number: 270.04
• Device Lot Number: 300517FQ
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/28/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1