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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 270.05
Device Problems Break (1069); Material Rupture (1546)
Patient Problem No Information (3190)
Event Date 12/26/2017
Event Type  malfunction  
Manufacturer Narrative
The malfunctioning device will be returned to vygon for evaluation as part of the complaint investigation. We have checked the history of complaints on these devices and only one of this batch was registered for rupture of the tube during infusion. The batch review do not shown any deviation or non-conformity. The tensile strength is compliant with the standard iso 10555-1. The values are greater than the specification of mini 10n. The average is 20,1n with a minimum at 16,9n.
 
Event Description
At the end of inserting the umbilical catheter, the hub break from the catheter tube. This catheter was removed and replaced by another one. No further information are available. Furthermore, no patient outcome has been reported.
 
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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 lacroix
2750 morris road
lansdale, PA 19446
8004735414
MDR Report Key7276610
MDR Text Key100446828
Report Number2245270-2018-00004
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,health
Type of Report Initial,Followup
Report Date 05/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number270.05
Device Lot Number031115FQ
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/24/2018
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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