MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 270.04

Device Problems Material Fragmentation (1261); Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Hematoma (1884); Abdominal Distention (2601); Foreign Body In Patient (2687)

Event Date 01/21/2024

Event Type  Injury  

Manufacturer Narrative

From the description, this umbilical catheter was not inserted in correct position, therefore this serious adverse event is not linked to the quality of our device.These complications are associated with the placement of umbilical catheters.For information, all umbilical catheters are controlled , including 100% tests carried out on each catheter during the manufacturing process.These tests are as follows: the bluntness of the catheter tip , marking the catheters and tightness.Our devices are compliant to norm iso 10555-1.In the ifu there cautions as follows : control of positioning : always check the location of the catheter by radiography.For umbilical arterial catheterization, the catheter can be sited either in the high position between thoracic vertebrae t6 and t9 or the low position at l3 to l5 level though the higher position is associated with lower complication rates.From our historical analysis of complaints, these 3 last years on all umbilical catheter range code 270.Xx, there was no other occurrence of similar adverse event.The involved sample for investigation has been discarded.

Event Description

Preterm of 34 weeks, weight 1700 gr.3 days old.Umbilical catheter inserted on 18th january, position controlled by x-ray after its insertion.The position was in low position at t10 and +1cm was inserted until mark 8 of the umbilical catheter.No additional controlled by x-ray has been done.Deterioration in the clinical condition of the newborn on 21 january , with a distended abdomen, abdominal venous collateral circulation.Carrying out an x-ray of the abdomen and an abdominal ultrasound showing a left hepatic hematoma associated with a subcapsular hematoma appearing to have ruptured in the peritoneal cavity.The end of the ktvo is found at the level of the portal trunk.Surgical management not indicated.Removal of the poorly positioned ktvo and transfer to intensive care for further treatment.Hemorrhagic shock requiring a transfusion of 30 ml.

• 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: 18730750
• MDR Text Key: 335721702
• Report Number: 2245270-2024-00018
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K921374
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 270.04
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• 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
• Patient Age: 3 DA
• Patient Weight: 2 KG