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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 270.04
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)
Event Date 02/06/2020
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. No non-conformities of the batch history records detected. The products are in conformity with the specifications. The device is compliant to iso norm 10555-1. The tensile strength is higher than 10n which is the norm minimum value. There is no other complaint on this batch.
 
Event Description
An umbilical catheter was introduced. Then x-ray was done. The catheter was broken during correction of the position of this catheter. Urgent consultation of a pediatric specialist. Removal of the entire fragment of the umbilical catheter. The patient feels good, his condition is stable.
 
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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 
4735414237
MDR Report Key9762534
MDR Text Key181402413
Report Number2245270-2020-00010
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
PMA/PMN Number
K921374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number270.04
Device Catalogue Number270.04
Device Lot Number070119FQ
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2020
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

Patient Treatment Data
Date Received: 02/27/2020 Patient Sequence Number: 1
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