MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 270.05

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Liver Contusion (1953); Foreign Body In Patient (2687)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

We are waiting for the involved sample for investigation.We have checked the history of complaints, no further complaints are registered on this batch.The batch review does not shown any deviation or non-conformity.

Event Description

The umbilical catheter was inserted on the (b)(6) 2017 for parenteral nutrition.The (b)(6) a hepatomegaly was discovered by xr.This catheter was 8 days in place.On (b)(6) by xr confirmed by abdominal ultrasound , intrahepatic liquid was noticed, approximately 60cm3.On (b)(6) with epicutaneous catheter ntp passing.Patient stable evolution.On (b)(6) ultrasound control shows decrease of intrahepatic collection.On (b)(6) patient weight (b)(6), abdominal collection has decreased by 75%, was allowed to go home with ambulatory "kangaroo".We have no information related to the umbilical catheter removal.Furthermore, the link between the hepatomegaly and the umbilical catheter is not clearly established.

Manufacturer Narrative

Mdr report 2245270-2018-00069 replaces 2245270-2019-00069.The involved sample is not available and we don't receive any additionnal information from the user.There is no further investigation or information about this event.We have checked the history of complaints, no further complaints are registered on this batch.The batch review does not shown any deviation or non-conformity.

Event Description

The umbilical catheter was inserted on the (b)(6) 2017 for parenteral nutrition.The (b)(6) a hepatomegaly was discovered by xr.This catheter was 8 days in place.On (b)(6) by xr confirmed by abdominal ultrasound , intrahepatic liquid was noticed , approximately 60cm3.On (b)(6) with epicutaneocatheter ntp passing.Patient stable evolution.On (b)(6) ultrasound control shows decrease of intrahepatic collection on (b)(6) patient weight 1868, abdominal collection has decreased by 75%, was allowed to go home with ambulatory "kangaroo".We have no information related to the umbilical catheter removal.Furthermore, the link between the hepatomegaly and the umbilical catheter is not clearly established.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen, 95440 ; FR 95440
• MDR Report Key: 7953303
• MDR Text Key: 123358020
• Report Number: 2245270-2018-00069
• 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: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 270.05
• Device Catalogue Number: 270.05
• Device Lot Number: 231115FQ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1