MAUDE Adverse Event Report: VYGON USA UMBILICAL CATHETER

Model Number 1270.03

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

The failed device 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.

Event Description

Ra line removed due to leakage.Resistance felt upon removal.The line was found to cracked/severed upon removal.

Manufacturer Narrative

We have received the sample for investigation.Analysis of the sample shows that it is torn off at the 6 cm marking.The break is not clear, the tube seems to have undergone an overpressure and the tube seems to have been stretched.The customer described that the catheter was removed due to leakage, however, after the tightness test of the catheter under water (with 3 bar of pressure), no leakage could be noticed on the device.It is identified in the product ifu:" the catheter is removed by gentle sustained traction close to the exit site (2-3 cm).Do not over stretch the catheter".The source of the defect is linked to the conditions of use therefore, no further corrective action will be initiated by quality management.The batch file review did not show any anomalies.The results of the tensile tests are in accordance with specifications of 10n.(average 19.4 n).This product is tested 100% during the production concerning detection of leakage and non-obstruction.Corrective action.Based on the investigation, this issue could not be traced to a quality defect of the product; therefore, no further corrective action will be initiated at this time.This failure will be monitored for future actions.

Event Description

Ra line removed due to leakage.Resistance felt upon removal.The line was found to cracked/severed upon removal.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON USA; 2750 morris road; lansdale PA 19446
• MDR Report Key: 11815939
• MDR Text Key: 250821922
• Report Number: 2245270-2021-00076
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• PMA/PMN Number: K921352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1270.03
• Device Catalogue Number: 1270.03
• Device Lot Number: 311019PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1