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Model Number 270.03
Device Problems Break (1069); Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 07/28/2021
Event Type  Death  
Manufacturer Narrative
The failed device will be 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 on the picture, we noticed the suture on the catheter, but the marking cannot be read, and the broken surface is not clear. We cannot see if the catheter has been damaged. The batch review does not show any non-conformity. The products are in conformity with the specifications. The device is compliant to norm iso 10555-1. The tensile strength measured values are all above the minimum value of iso norm, 10 newton. The tightness and the rounded tip of each umbilical catheter are controlled. There are no other complaints with this batch. The historical data analysis of the last 3 years regarding this product, shows that one catheter rupture occurred in 2019 during the dressing removal. The catheter was cut. No patient injury occurred. From this information, we cannot determine the cause of the rupture. It is well-known, that a premature baby of (b)(6) has a survival chance of 50%. There are many causes of death of a very large premature infant.
Event Description
A premature baby of (b)(6) and weighing (b)(6) is born at 0. 39 am on (b)(6). An umbilical venous catheter was inserted at 1. 00 am as central venous catheter for parenteral infusion and medication. Its correct placement and location have been checked by xr at 1. 37 am. The catheter has been fixed by a suture. At 5. 00 am the dressing has been changed because it was wet. The last control of the catheter and its insertion site was done at 6. 00 am. 7 hours after its insertion the catheter was found broken at some cm from its insertion. At 9. 30 am the premature died. A picture of the broken catheter has been sent.
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Manufacturer (Section D)
5 rue adeline
ecouen 95440
FR 95440
Manufacturer (Section G)
5 rue adeline
ecouen 95440
FR 95440
Manufacturer Contact
freda o lacroix
2750 morris road
lansdale, PA 19446
MDR Report Key12312188
MDR Text Key266174576
Report Number2245270-2021-00099
Device Sequence Number1
Product Code FOS
Combination Product (y/n)Y
Reporter Country CodeFR
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number270.03
Device Catalogue Number270.03
Device Lot Number301020PA
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received07/30/2021
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: 08/12/2021 Patient Sequence Number: 1