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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 1272.14
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Liver Contusion (1953); Liver Laceration(s) (1955)
Event Date 02/01/2019
Event Type  Injury  
Manufacturer Narrative
As batch is unknown, no review can be done. All umbilical catheters are 100% tested for tightness and non-obstruction during the manufacturing process. The sample has not been retained. No further investigation can be done.
 
Event Description
The event occured (b)(6) 2019 on a preterm infant (b)(6). The device was in until day 8 of baby's life. Liver injury following the use of the umbilical catheter. It is likely to be a liver haematoma but cannot exclude tpn/blood extravasation. The device has been removed.
 
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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 Key8641350
MDR Text Key146095297
Report Number2245270-2019-00028
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
PMA/PMN Number
K981630
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 02/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1272.14
Device Catalogue Number1272.14
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2019
Was Device Evaluated by Manufacturer? No
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: 05/24/2019 Patient Sequence Number: 1
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