MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 1274.14

Device Problems Break (1069); Separation Failure (2547); Separation Problem (4043)

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

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

The device will be returned for evaluation as part of the complaint investigation.The results of this investigation are still pending,and will be reported to fda within thirty days of its conclusion via follow-up mdr.

Event Description

The umbilical catheter was inserted on (b)(6) 2021 in a newborn baby.After 4 days, the catheter was found disconnected from its hub.The part coming out of the umbilical cord was totally disconnected from the infusion with blood flowing back to the catheter.The other part connected to the infusion was found in the incubator.The catheter was immediately removed and replaced with a peripheral central catheter no patient injury occured.

Manufacturer Narrative

We received the involved sample for investigation.The sample is in two parts : one with proximal and distal lumen attached to junction hub and the second part which is 35,7cm of the umbilical catheter for a nominal length of 40cm.We noticed that the distal tip is missing from marking 5cm and that the catheter is detached from its junction hub.On visual examination a circular mark on the tube was identified and confirms the correct insertion of the tube in its junction hub.Furthermore, glue is noticed inside the junction hub.This confirms the gluing process of the catheter.The dimensions of the tube and of the hub are compliant.The root cause of this event cannot be defined.The most likely cause would be linked to its use and probably to a mechanical stress applied on the tube.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 is higher than 10 newton which is the norm minimum value.Historical analysis of the data of incidents of the last 3 years, shows that there is no similar incident.

Event Description

The umbilical catheter has been inserted the (b)(6) 2021 on a new born baby.After 4 days, the catheter was found disconnected from its hub.The part coming out of the umbilical cord was totally disconnected from the infusion with blood flowing back to the catheter.The other part connected to the infusion was found in the incubator.The catheter has been immediately removed and replaced by a peripheral central catheter.No patient injury occured.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• MDR Report Key: 11304745
• MDR Text Key: 232378826
• Report Number: 2245270-2021-00009
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1274.14
• Device Catalogue Number: 1274.14
• Device Lot Number: 160720EI
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1