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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 270.03200518FR, 060318FR OR 141117FR
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)
Event Date 05/01/2019
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 of the 3 supplied batches shows that the 3 batches are conforms to the specifications. There is no similar complaint reported on these 3 batches.
 
Event Description
The event occured the (b)(6) 2019 on a baby. The device stays 4 days in the patient. The umbilical catheter snapped while being taken out. The distal end of the uac remained in the baby and had to be removed by surgical exploration. The baby is currently doing well and is stable. Both ends of the catheter are available. There are 3 probable batch numbers : 200518fr, 060318fr or 141117fr.
 
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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 Key8645583
MDR Text Key146222172
Report Number2245270-2019-00030
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 07/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number270.03200518FR, 060318FR OR 141117FR
Device Catalogue Number270.03
Device Lot Number200518FR, 060318FR OR 141117FR
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2019
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: 05/28/2019 Patient Sequence Number: 1
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