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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 Code Available (3191)
Event Date 08/21/2019
Event Type  Injury  
Manufacturer Narrative
The malfunctioning device will be returned to vygon for evaluation as part of the complaint investigation. The results of this investigation are pending and will be communicated to fda within 30 days of its conclusion via follow up mdr.
 
Event Description
Antenatally diagnosed lumbosacral myeomeningocele. Operated on (b)(6) 2019. On the early hours of (b)(6) 2019 bleeding was noted around umbilical cord. Resident consultant examined and noted that there was bleeding originating from the catheter at the point of entry into the stump suggestive of break in the catheter. Uvc removed immediately to apply effective pressure. Tried to remove uac which snapped at the junction. Thus nearly 21 cm of catheter remained in situ. Bleeding controlled immediately with a metallic clamp. Surgical team informed. Parents consented for exploration and removal of arterial catheter. Catheter successfully removed in the pediatric surgical theatre.
 
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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 Key9097387
MDR Text Key161435969
Report Number2245270-2019-00056
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
PMA/PMN Number
K851005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 09/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
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 Number180718FQ
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/20/2019 Patient Sequence Number: 1
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