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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 1274.14
Device Problems Positioning Failure (1158); Malposition of Device (2616)
Patient Problem Pericardial Effusion (3271)
Event Date 02/08/2021
Event Type  Injury  
Manufacturer Narrative
The device will be returned for evaluation as part of the complaint investigation. The results of this investigation are still pending,and will be reported to fda within thirty days of its conclusion via follow-up mdr. 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 similar complaint on this batch. The umbilical catheter was functioning during 4 days without any problem.
 
Event Description
A pericard effusion was noticed by pulmonary rx and cardiac echography. The umbilical catheter has been removed and 4ml of liquid has been withdrawn. Placement controls have been done after its insertion and than on 08 and 09 february in order to control the pneumothorax, the catheter was correct. The umbilical catheter has been inserted on 05 february and during the night of 09 february, a deterioation in state of health was noticed. On 11 february the child was doing well and the effusion improved.
 
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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 Key11561400
MDR Text Key244184939
Report Number2245270-2021-00023
Device Sequence Number1
Product Code FOS
Combination Product (y/n)Y
PMA/PMN Number
K981630
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1274.14
Device Catalogue Number1274.14
Device Lot Number030718EI
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2021
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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