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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 1270.03
Device Problem Positioning Problem (3009)
Patient Problems Death (1802); Pericardial Effusion (3271)
Event Date 04/27/2020
Event Type  Death  
Manufacturer Narrative
The umbilical catheter is not available, it was discarded. The batch review confirms that the product are compliant. The user confirms that the position of the catheter is correct. This serious adverse event is not linked to the catheter. The chorioamnionitis and the initial state of health are the most likely origin of this clinical degradation.
 
Event Description
The serious adverse event occured (b)(6) 2020. A (b)(6) gestation infant born on (b)(6) 2020 in an amnionitis context. An umbilical venous catheter was inserted on the day of birth. The position of the catheter has been checked. During the night of (b)(6), a clinical degradation of the state of health were noticed. Pericardial and peritoneal effusion. Cardiac massage during 20 minutes. Baby died on (b)(6) 2020.
 
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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 Key10114991
MDR Text Key193673885
Report Number2245270-2020-00031
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
Report Date 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1270.03
Device Catalogue Number1270.03
Device Lot Number070819PA
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/03/2020 Patient Sequence Number: 1
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