MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 1272.04

Device Problems Break (1069); Migration (4003)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

The failed sample 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.Batch analysis of both possible batches did not show any discrepancy.The products are in accordance with the specifications.The devices comply with the iso 10555-1 standard.The tensile strength measured values are all above the minimum value of iso norm.This is the first complaint in the same batch.

Event Description

During the insertion of an umbilical catheter to a baby , the catheter broke cleanly and spontaneously.A temporary migration has been reported.The pediatrician pressed on the liver, making it possible to remove the broken part.No scissors were on the drape.

Event Description

During the insertion of an umbilical catheter to a baby , the catheter broke cleanly and spontaneously.A temporary migration has been reported.The pediatrician pressed on the liver, making it possible to remove the broken part.No scissors were on the drape.

Manufacturer Narrative

We received the involved sample catheter in 2 parts for investigation.The tube's fracture is located between the marking 8 and 9.We noticed a suture around the catheter at marking 10.On examination of the fracture surfaces of both parts, a smooth surface was identified.This is characteristics of a damage by a sharp object causing the fracture.Therefore, the root cause of the fracture is not a defect of the catheter.The root cause of the rupture is traced to the user.The batch review of both possible batches does not show any non-conformity.The products are in conformity with the specifications.The devices are compliant to norm iso 10555-1.The tensile strength measured values are all above the minimum value of iso norm.The historical complaint's data analysis of both possible batches, shows that there are no other complaint.

• 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 o lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 12983675
• MDR Text Key: 283750615
• Report Number: 2245270-2021-00127
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K981630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1272.04
• Device Lot Number: 160221EK OR 120618EJ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2021
• 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 Sequence Number: 1