MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 270.04

Device Problems Complete Blockage (1094); Obstruction of Flow (2423)

Patient Problem No Information (3190)

Event Date 10/01/2018

Event Type  malfunction  

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After insertion of the umbilical catheter, there was no veinous blood return.The umbilical catheter has been withdrawn and replaced by a second one.

Event Description

After insertion of the umbilical catheter there was no veinous blood return.The umbilical catheter has been withdrawn and replaced by a second one.

Manufacturer Narrative

The sample for the event#: (b)(4) was not kept.Therefore further investigation is not possible.The root cause of the obstruction cannot be defined.It seems not be linked to a device defect.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.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen, 95440 ; FR 95440
• MDR Report Key: 8011130
• MDR Text Key: 125277416
• Report Number: 2245270-2018-00075
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2018
• 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?: No
• Date Manufacturer Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1