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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 Problems Break (1069); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/30/2020
Event Type  malfunction  
Manufacturer Narrative
The failed device was 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
Catheter not intact. Removed with difficulty. Catheter broken at green colored hub.
 
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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 Key11338516
MDR Text Key232598443
Report Number2245270-2021-00014
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K981630
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1272.14
Device Catalogue Number1272.14
Device Lot Number140819EJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2021
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

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