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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 1270.05
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/06/2020
Event Type  Injury  
Manufacturer Narrative
The failed sample will be returned to vygon for device evaluation as part of the complaint investigation. The results of this investigation are still pending,and will be communicated to fda within 30 days of its conclusion. The batch review does not shown any non-conformity. The products are in conformity with the specifications. The device is compliant to norm iso (b)(4). The tensile strength is higher than 10 newton which is the norm minimum value. There is no other complaint on this batch.
 
Event Description
During its withdrawal the umbilical catheter broke. The broken part remaining in the baby could be removed by the medical team and an occlusive dressing was done. 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 Key11126460
MDR Text Key225559216
Report Number2245270-2021-00002
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 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1270.05
Device Catalogue Number1270.05
Device Lot Number301118AL
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/24/2020
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: 01/06/2021 Patient Sequence Number: 1
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