MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 1272.14

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/23/2019

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.The batch review shows that it is compliant to its specification.No deviation is registered.There is no complaint reported on this batch.

Event Description

A preterm infant had a uvc in situ (6cm at stump) in order to receive tpn.As she was tolerating full enteral feeds, the uvc was clamped at approximately 02:00 by myself in preparation for removal.I requested for the annp to come and remove it at approximately 03:30.As the procedure was being performed, the catheter snapped at 5cm.The annp had commented that it was difficult and had soaked the stump with chlorohexidine and a gauze swab.Deterioration of patient.Patient transferred to tertiary centre for ongoing treatment.The neonatal registrar was contacted immediately who came to review the patient.An abdominal and chest x-ray was performed.The consultant on call was contacted by the registrar and a plan was initiated to transfer the infant to the local tertiary centre for the remaining part of the catheter to be surgically removed.Surgical removal of the remainder of the line.The unit have advised that the baby is back and doing well following a laparotomy to remove the remainder of the line.

Event Description

A preterm infant had a uvc in situ (6cm at stump) in order to receive tpn.As she was tolerating full enteral feeds, the uvc was clamped at approximately 02:00 by myself in preparation for removal.I requested for the annp to come and remove it at approximately 03:30.As the procedure was being performed, the catheter snapped at 5cm.The annp had commented that it was difficult and had soaked the stump with chorohexidine and a gauze swab.Deterioration of patient.Patient transferred to tertiary centre for ongoing treatment.The neonatal registrar was contacted immediately who came to review the patient.An abdominal and chest x-ray was performed.The consultant on call was contacted by the registrar and a plan was initiated to transfer the infant to the local tertiary centre for the remaining part of the catheter to be surgically removed.Surgical removal of the remainder of the line.The unit have advised that the baby is back and doing well following a laparotomy to remove the remainder of the line.

Manufacturer Narrative

During the investigation, a catheter fracture was identified 164mm from the hub.Examination under the sem, raised aspects and striations were identified on the fracture surface along with rough and smooth areas.A cut was also identified transecting the catheter.Upon further examination, a further area of damage was identified approximately 2mm above the fracture surface.On examination under the microscope, a v-shaped cut was identified.From previous investigations and laboratory recreation testing, we can advise that the damage identified is consistent with the catheter coming into contact with a suture needle during, or shortly after, insertion.The damage caused by the suture needle will have significantly weakened the catheter, resulting in a complete fracture on the application of a tensile (pulling) force during removal.The batch review shows that it is compliant to its specification and no deviation registered.There is no other complaint reported on this batch.This event is not linked to a quality defect of this device but to the conditions of use.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• MDR Report Key: 9097378
• MDR Text Key: 163823520
• Report Number: 2245270-2019-00059
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• PMA/PMN Number: K981630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1272.14
• Device Catalogue Number: 1272.14
• Device Lot Number: 080219EJ
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention