MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 1270.05

Device Problem Fluid Leak (1250)

Patient Problems Extravasation (1842); Angioedema (4536)

Event Date 01/18/2021

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. 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 other complaint on this batch and no similar complaint on this product reference. Extravasation could be a complication due to a vessel perforation or a weakness of the vessel wall.

Event Description

Extravasation of tpn fluid in the surrounding tissues through the umbilical catheter. An oedema is located and the infusion stopped. The umbilical catheter has been removed and replaced by a peripheral venous catheter. No further information related to the placement control, the use duration and to the patient are available.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• Manufacturer (Section G): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• Manufacturer Contact: freda o lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 11371916
• MDR Text Key: 246841752
• Report Number: 2245270-2021-00016
• 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: 04/22/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 1270.05
• Device Catalogue Number: 1270.05
• Device Lot Number: 090720PA
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial