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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGON USA UMBILICAL CATHETER
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VYGON USA UMBILICAL CATHETER Back to Search Results
Model Number 1272.14
Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2022
Event Type  malfunction  
Event Description
At beginning of shift, uvc insertion site visible at 5.5cm mark.During 0100 assessment, uvc site wet.Top duo-derm lifted off of abdomen.Bottom duo-derm and layer of tega-derm still intact, with line split in two pieces under tega-derm.
 
Manufacturer Narrative
The failed device was returned to vygon for evaluation and complaint investigation.The results of this investigation are still pending,and will be communicated to fda within 30 days of its conclusion.
 
Manufacturer Narrative
The complaint was forwarded to our parent company in france for their evaluation.The investigation summary is as follows: we received one sample for investigation.Analysis of the sample received shows that the catheter is cut in two parts, the first part under the two lumens measures 14 cm, the other part measures 7 cm, presence of a suture at 4 cm from the blunt end of the catheter.The cut is clean, angled at the break.It appears that the cause is linked to the use of a sharp object there is a statement in our product's ifu: do not apply instruments with sharp or rough edges directly to the catheter: even a minor cut could tear or break it.As the catheter worked well for 11 days, we do not believe this is related to manufacturing defect therefore, no further corrective action is initiated by quality management.Corrective action: based on the investigation, this issue could not be traced to manufacturing defect; therefore, no further corrective action will be initiated at this time.
 
Event Description
At beginning of shift, uvc insertion site visible at 5.5cm mark.During 0100 assessment, uvc site wet.Top duo-derm lifted off of abdomen.Bottom duo-derm and layer of tega-derm still intact, with line split in two pieces under tega-derm.
 
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Brand Name
UMBILICAL CATHETER
Type of Device
UMBILICAL CATHETER
Manufacturer (Section D)
VYGON USA
2750 morris road
lansdale PA 19446
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 Key15077912
MDR Text Key303091494
Report Number2245270-2022-00065
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 Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1272.14
Device Catalogue Number1272.14
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received07/18/2022
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 Sequence Number1
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