MAUDE Adverse Event Report: VYGON SA UMBILICAL CATHETER

Catalog Number 270.05

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 02/25/2016

Event Type  Death  

Manufacturer Narrative

Investigation result: the catheter works correctly 3 days after placement.The x-ray controls shows no catheter's anomaly.We have analyzed the involved catheter.The catheter is not damaged.We noticed no catheter leakage.Its tip and the dimension are compliant.During the manufacturing process a 100% tightness control is performed on each umbilical catheter prior packing.This confirmed the x-ray control; no catheter's anomaly has been detected.As no post mortem examination has been done, we could not known if any perforation occurred.

Event Description

An umbilical catheter has been inserted on a premature baby (b)(6) just after his birth on (b)(6) 2016.The insertion of umbilical catheter and the location were correct; the central position has been checked by x-ray control.The administration of infusion has been done until (b)(6) without any problem.On (b)(6), the baby's health deteriorates, a peritoneal effusion is detected.The location of the catheter is checked , it stays in the central position.The patrician removed it from 2cm, no improvement of baby's health.The baby is shocked and he died on (b)(6).The death seems not to be linked to the catheter.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON SA; 5 rue adeline; ecouen, 95440 ; FR 95440
• Manufacturer (Section G): VYGON SA; 5 rue adeline; ecouen, 95440 ; FR 95440
• Manufacturer Contact: jillian mikovich ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 5520997
• MDR Text Key: 41006893
• Report Number: 2245270-2016-00007
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• PMA/PMN Number: K851005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 270.05
• Device Lot Number: 090415FP
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 4 DA
• Patient Weight: 2