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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 Material Fragmentation (1261); Material Rupture (1546)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/18/2018
Event Type  Injury  
Manufacturer Narrative
We received for the involved sample for investigation. The visual examination shows that a cut can be noticed between the graduations 9 and 10. Both extremities are sharp and beveled, which is characteristic of a cut occured by a scalpel blade or a sharp object during its use. See enclosed picture. The most likely root cause of this incident is not linked to a catheter defect but to its conditions of use. We have checked the history of complaints, no further complaints are registered on this batch. The batch review does not shown any deviation or non-conformity.
 
Event Description
After asepsis and antisepsis, functional tests are performed irrigating saline solution, the umbilical artery is located, a catheter is passed without complications until it reaches 11cm. The umbilical vein is located and a 6cm catheter is placed, suddenly, according to the institutional protocol. Bleeding is observed at the arterial catheter insertion site and the total catheter rupture is corroborated clinically. It proceeds to inspect, trying to recover line, without success. Abdominal radiography is requested, showing aortic catheter and part of the intracardiac tract. Interconsultation is requested with the pediatric surgery and cardiovascular surgery service. The patient is stable, in suitable general conditions, without apparent deterioration, with vital signs ta: 57/35, fc: 139, fr: 56. 5%, o2: 98.
 
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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 Key7995380
MDR Text Key124713931
Report Number2245270-2018-00072
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
Report Date 10/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number270.05
Device Lot Number220217FQ
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2018
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

Patient Treatment Data
Date Received: 10/23/2018 Patient Sequence Number: 1
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