MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 270.05

Device Problem Fluid/Blood Leak (1250)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

The failed sample will be returned to vygon for device evaluation as part of the complaint investigation.The results of this investigation are still pending,and will be communicated to fda within 30 days of its conclusion.As batch is unknown, no review can be done.All umbilical catheters are 100% tested for tightness and non-obstruction during the manufacturing process.

Event Description

After 62 hours, a leakage of parenteral infusion was noticed on the external part of the umbilical catheter.It has been withdrawn.A part of 4,5 cm remained in the vein and necessitated a surgical intervention with dissection of umbilical vein.It was replaced by a peripheral venous line.No patient injury and no patient outcome up today but the physician could not exclude a cavernoma later.Only, a control by ultrasound in a few months would confirm that there is no patient outcome.

Event Description

After 62 hours,a leakage of parenteral infusion was noticed on the external part of the umbilical catheter.It has been withdrawn.A part of 4,5 cm remained in the vein and necessitated a surgical intervention with dissection of umbilical vein.It was replaced by a peripheral venous line.No patient injury and no patient outcome up today but the physician could not exclude a cavernoma later.Only, a control by ultrasound in a few months would confirm that there is no patient outcome.

Manufacturer Narrative

We received the involved umbilical catheter for evaluation.We noticed that the distal part of the tube has been pulled off.The catheter has been over stretched by the user.In the ifu the cautions are written as follows : -do not over stretch the catheter as it may rupture, causing embolism, -removal : the catheter is removed by gentle sustained traction close to the exist site( 2-3 cm).Do not over stretch the catheter.This event is not linked to a defect of the umbilical catheter.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen, 95440 ; FR 95440
• MDR Report Key: 8274830
• MDR Text Key: 134016718
• Report Number: 2245270-2019-00004
• 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: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 270.05
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 DA