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Catalog Number 1270.04
Device Problems Fluid Leak (1250); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/13/2017
Event Type  Injury  
Manufacturer Narrative
Our investigation is based on the deepening carried out the product specialist, who went to the nicu department to investigate the circumstances of the event and the procedures of implantation and management of the umbilical catheter. The investigation could not be based on the analysis of the sample, which has not been kept by users. As far as we know, an extravasation of the infused solutions can be caused by a primary or secondary malposition of the catheter, or by a crack in the intravascular portion of the catheter, already present before use or occurred during use. The extravasation would not seem to depend on a primary malposition, since the department systematically checks the positioning by rx, or by a secondary malposition, as the department adopts a fixing procedure that appears fully compliant, to our knowledge, to the clinical best practices. The extravasation would not seem to depend on any damage to the catheter before its use, or a non-conformity of production, either because the catheter was in use for several days without showing abnormalities and because the integrity of each vygon umbilical catheter is tested before its packaging, however, the lack of the sample makes it impossible to ascertain it with absolute certainty. Extravasation may be due to a crack in the catheter caused accidentally in the early stages of use, for example for the use of toothed clamps for advancing the catheter (which the department does not seem to use), or by a crack caused by an excess of pressure inside the catheter, for example for the use of small volume syringes (<10 ml) and / or for the presence of an occlusion (in literature often referred to the parenteral solution) which could have led to exceed the resistance limits of the catheter. During the manufacturing process a 100% tightness control is performed on each umbilical catheter prior packing (according to iso 10555-1) no similar event happened neither of the specific lot, nor of the product as a whole.
Event Description
Five (5) days after the insertion in a (b)(6) baby, the clinicians observed a leakage of milky liquid in the abdomen, which required a surgical procedure. Right after the insertion the position of the catheter has been confirmed in the cavoatrial junction via x-ray control. Parenteral nutrition, antibiotics and unknown drugs have been infused via syringe or syringe pump. The catheter got in touch with clorexidine 2% and betadine. The catheter has been fixed according to best practices with steri-strips and tegaderm. A surgical procedure was needed , the patient outcome is unknown. Unfortunately, the involved catheter was thrown away.
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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 lacroix
2750 morris road
lansdale, PA 19446
MDR Report Key7199894
MDR Text Key97532526
Report Number2245270-2018-00002
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeIT
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
Report Date 01/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1270.04
Device Lot Number140815AM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/23/2017
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

Patient Treatment Data
Date Received: 01/17/2018 Patient Sequence Number: 1