MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 1272.14

Device Problem Fluid/Blood Leak (1250)

Patient Problems Bacterial Infection (1735); Patient Problem/Medical Problem (2688)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

Although we do not know if the failed device will be returned to vygon, the details of the complaint will be examined as part of the complaint investigation.This investigation is currently in process and the results will be forwarded to fda within 30 days of its conclusion via follow-up mdr.All umbilical catheters are 100% tested for tightness and non-obstruction during the manufacturing process.No other complaint has been registered on this batch.

Event Description

After 3 days , a leakage were noticed at the junction of both catheter's lumen.A serious deterioration of the state of health with a bacteremia was reported.The actual state of health of the patient is unknown.

Manufacturer Narrative

The root cause of this event cannot be defined.As no device was returned for investigation.It is seems not due to a defect of our device.All umbilical catheters are 100% tested for tightness and non-obstruction during the manufacturing process.No other complaint was registered for this batch.

Event Description

After 3 days , a leakage were noticed at the junction of both catheter's lumen.A serious deterioration of the state of health with a bacteremia was reported.The actual state of health of the patient is unknown.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen, 95440 ; FR 95440
• MDR Report Key: 8893394
• MDR Text Key: 154432100
• Report Number: 2245270-2019-00045
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1272.14
• Device Catalogue Number: 1272.14
• Device Lot Number: 240517EJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1