MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 270.03200518FR, 060318FR OR 141117FR

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

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

Event Date 05/01/2019

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 of the 3 supplied batches shows that the 3 batches are conforms to the specifications.There is no similar complaint reported on these 3 batches.

Event Description

The event occured the (b)(6) 2019 on a baby.The device stays 4 days in the patient.The umbilical catheter snapped while being taken out.The distal end of the uac remained in the baby and had to be removed by surgical exploration.The baby is currently doing well and is stable.Both ends of the catheter are available.There are 3 probable batch numbers : 200518fr, 060318fr or 141117fr.

Manufacturer Narrative

The catheter fracture is confirmed on the sample's examination at 241mm from the hub : the visual examination does not shown any obvious sign of moulding deformation or of manufacturing material weakness.The fracture surface section were examined under microscope and it identified an uneven aspect with a raised aspect to one side and striations and also 2 cuts within the catheter surface.These striations are characteristics of the tubing having been inadvertently nicked or cut with a sharp implement i.E suture or scalpel.This also indicated by the 2 cuts.The raised aspects indicate the application of a tensile force having been applied to the tube and this force fractured completely the tube.This even is not linked to a product defect but to the conditions of use.The batch review of the 3 supplied batches shows that the 3 batches are conforms to the specifications.There is no similar complaint reported on these 3 batches.

Event Description

The event occured the (b)(6) 2019 on a baby.The device stays 4 days in the patient.The umbilical catherer snapped while being taken out.The distal end of the uac remained in the baby and had to be removed by surgical exploration.The baby is currently doing well and is stable.Both ends of the catheter are available.There are 3 probable batch numbers : 200518fr, 060318fr or 141117fr.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen, 95440 ; FR 95440
• MDR Report Key: 8645583
• MDR Text Key: 146222172
• Report Number: 2245270-2019-00030
• 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: 07/15/2019

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: 270.03200518FR, 060318FR OR 141117FR
• Device Catalogue Number: 270.03
• Device Lot Number: 200518FR, 060318FR OR 141117FR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 05/07/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention