MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 270.04

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

Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 02/06/2020

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.No non-conformities of the batch history records detected.The products are in conformity with the specifications.The device is compliant to iso norm 10555-1.The tensile strength is higher than 10n which is the norm minimum value.There is no other complaint on this batch.

Event Description

An umbilical catheter was introduced.Then x-ray was done.The catheter was broken during correction of the position of this catheter.Urgent consultation of a pediatric specialist.Removal of the entire fragment of the umbilical catheter.The patient feels good, his condition is stable.

Manufacturer Narrative

We have received the involved umbilical catheter.The visual examination of the involved umbilical catheter shows that it is broken between the centimetrics mark 9 and 10 cm.On the fractured surface we noticed an even area and v part.This is characteristic of a damaged tube by the cut of a sharp object , on which a mechanical force has been applied.The damage caused probably by a forceps has significantly weakened the catheter, resulting in a complete fracture on the application of a tensile (pulling) force during the correction of the catheter's position.The tensile strength results during manufacturing are all above the iso norm value of 10n.The minimum measured value is 16,7n.The historical data analysis , shows that there is no other complaint on this batch.This event is not linked to a quality defect of this device but its conditions of use.In the instruction of use, we recommend to use non-toothed forceps.

Event Description

An umbilical catheter was introduced.Then x-ray was done.The catheter was broken during correction of the position of this catheter.Urgent consultation of a pediatric specialist.Removal of the entire fragment of the umbilical catheter.The patient feels good, his condition is stable.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• MDR Report Key: 9762534
• MDR Text Key: 181402413
• Report Number: 2245270-2020-00010
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• PMA/PMN Number: K921374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 270.04
• Device Catalogue Number: 270.04
• Device Lot Number: 070119FQ
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention