Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

VYGON UMBILICAL CATHETER Back to Search Results
Model Number 1270.05
Device Problem Fluid/Blood 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.
 
Manufacturer Narrative
The sample has been returned for evaluation.The investigation summary is as follows: the visual examination shows that the catheter is conform, no anomaly could be noticed.The catheter has been tested, there is no obstruction.The tightness was checked under air pressure, there is no leakage.The distal tip of the catheter is rounding as expected.Furthermore, these umbilical catheters are 100% checked during the manufacturing process.This event is not linked to a defect of the catheter.The user has no further information concerning the regular check of the position of this catheter and its insertion date.Extravasation is a well-known complication of catheters.The batch review does not show any non-conformity.The products are in conformity with the specifications.The device is compliant to norm iso 10555-1.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.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UMBILICAL CATHETER
Type of Device
UMBILICAL CATHETER
Manufacturer (Section D)
VYGON
5 rue adeline
ecouen 95440
FR  95440
MDR Report Key11371916
MDR Text Key246841752
Report Number2245270-2021-00016
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
PMA/PMN Number
K921352
Number of Events Reported1
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
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number1270.05
Device Catalogue Number1270.05
Device Lot Number090720PA
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-