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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

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VYGON UMBILICAL CATHETER Back to Search Results
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.
 
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Brand NameUMBILICAL CATHETER
Type of DeviceUMBILICAL 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 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
0 Patients were 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
Device Model Number1270.05
Device Catalogue Number1270.05
Device Lot Number090720PA
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2021
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

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