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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 Break (1069); Separation Failure (2547); Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2021
Event Type  malfunction  
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.
 
Event Description
The umbilical catheter was inserted on (b)(6) 2021 in a newborn baby. After 4 days, the catheter was found disconnected from its hub. The part coming out of the umbilical cord was totally disconnected from the infusion with blood flowing back to the catheter. The other part connected to the infusion was found in the incubator. The catheter was immediately removed and replaced with a peripheral central catheter no patient injury occured.
 
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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 Key11304745
MDR Text Key232378826
Report Number2245270-2021-00009
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 04/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2021
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 Number160720EI
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2021
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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