MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 1274.14

Device Problems Positioning Failure (1158); Malposition of Device (2616)

Patient Problem Pericardial Effusion (3271)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

The device will be returned for evaluation as part of the complaint investigation.The results of this investigation are still pending,and will be reported to fda within thirty days of its conclusion via follow-up mdr.The batch review does not shown any non-conformity.The products are in conformity with the specifications.The device is compliant to norm iso (b)(4).The tightness and the rounded tip of each umbilical catheter are controlled.There is no similar complaint on this batch.The umbilical catheter was functioning during 4 days without any problem.

Event Description

A pericard effusion was noticed by pulmonary rx and cardiac echography.The umbilical catheter has been removed and 4ml of liquid has been withdrawn.Placement controls have been done after its insertion and than on 08 and 09 february in order to control the pneumothorax, the catheter was correct.The umbilical catheter has been inserted on 05 february and during the night of 09 february, a deterioation in state of health was noticed.On 11 february the child was doing well and the effusion improved.

Manufacturer Narrative

The visual examination shows that the catheter is conform, no anomaly could be noticed.The catheter has been tested, there is no leakage.The distal tip of the catheter is rounding as expected.Furthermore, these umbilical catheters are 100% checked during the manufacturing process.This reported event is not linked to a defect of the catheter.Extravasation is a well known complication of catheters.The batch review does not shown any non-conformity.The products are in conformity with the specifications.The device is compliant to norm iso 10555-1.The tightness and the rounded tip of each umbilical catheter are controlled.There is no similar complaint on this batch.The umbilical catheter works for 4 days without any problems.As the umbilical catheter works for 4 days without any problem, we do not believe this is a quality defect of the product and no further corrective action is initiated by quality management.

Event Description

A pericard effusion was noticed by pulmonary rx and cardiac echography.The umbilical catheter has been removed and 4ml of liquid has been withdrawn.Placement controls have been done after its insertion and than on 08 and 09 february in order to control the pneumothorax, the catheter was correct.The umbilical catheter has been inserted on 05 february and during the night of 09 february, a deterioation in state of health was noticed.On 11 february the child was doing well and the effusion improved.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• MDR Report Key: 11561400
• MDR Text Key: 244184939
• Report Number: 2245270-2021-00023
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): Y
• PMA/PMN Number: K981630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1274.14
• Device Catalogue Number: 1274.14
• Device Lot Number: 030718EI
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1