MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Catalog Number 1270.04

Device Problems Fluid/Blood 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.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL 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 Key: 7199894
• MDR Text Key: 97532526
• Report Number: 2245270-2018-00002
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K921352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 1270.04
• Device Lot Number: 140815AM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/23/2017
• Initial Date FDA Received: 01/17/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention