MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 1270.05

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/06/2020

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 does not shown any non-conformity.The products are in conformity with the specifications.The device is compliant to norm iso (b)(4).The tensile strength is higher than 10 newton which is the norm minimum value.There is no other complaint on this batch.

Event Description

During its withdrawal the umbilical catheter broke.The broken part remaining in the baby could be removed by the medical team and an occlusive dressing was done.No patient injury occured.

Manufacturer Narrative

We received the involved umbilical catheter for investigation.Under microscopic examination, we noticed a smooth area on the fractured surface at 95 mm from the distal end.It is characteristic of a cut with a sharp object.No manufacturing issues were identified in this investigation.The tensile strength of the restored catheter is 43n.Furthermore the diameters of the tube are complaints.The batch review does not shown 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.There is no other complaint on this batch.From the description of the complaint the rupture occured during its removal and it worked without any problems during the period of use.The most likely root cause is an unintended cut of the umbilical catheter during its removal.

Event Description

During its withdrawal the umbilical catheter broke.The broken part remaining in the baby could be removed by the medical team and an occlusive dressing was done.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: 11126460
• MDR Text Key: 225559216
• Report Number: 2245270-2021-00002
• 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: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1270.05
• Device Catalogue Number: 1270.05
• Device Lot Number: 301118AL
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention