MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 1270.03

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

Two occurrences of this malfunction were reported to vygon, the details of the other can be found in mdr 2245270-2020-00090.One sample will be returned to vygon and will be evaluated as part of the complaint investigation.The results of this investigation are still pending and will be communicated with fda within 30 days of completion.

Event Description

Catheter cracked at the connection of the line to the luer lock.

Manufacturer Narrative

Review of the reported invent showed that the duration of use of catheters, 41 and 66 days, greatly exceeded the standard short-term catheterization of the umbilical vessels.The prescribed regulatory "short term" is less than 30 days.Vygon certifies our catheters for 29 days of use.The sample received included one used catheter and a competitor's lock for investigation.Visual analysis revealed the presence of dried blood and medication.The competitor's lock is connected at the hub of the umbilical catheter.Furthermore, two sutures were observed around the tube and traces of dressing / compressed filament.The tightness test reveals a leak very close to the hub.The surface of the tube is even and characteristic of a cut by a sharp object.The cut is observed on about 50% of the diameter of the tube.Dimensional examination of the tube shows that it conforms to specifications.Please note that a flow and tightness control are achieved in production at 100%.These controls ensure that the product was compliant after production.As the umbilical catheter was functioning correctly for a long period of time, this defect is not traced to a quality defect of the product.The analysis showed that the leak was caused by a cut made by a sharp object such as scalpel or scissors.Moreover, the duration of use of catheters has greatly exceeded the prescribed limit.The reported anomaly is therefore attributable to improper use.The batch file review of the two possible batches did not show any anomalies.This problem has not been reported in these batches.As the umbilical catheter worked well for 66 days and 41 days, we do not believe this is a quality defect of the product and no further corrective action is initiated by quality management corrective action.Based on the investigation, this issue could not be traced to a quality defect of the product; therefore, no further corrective action will be initiated at this time.This failure will be monitored for future actions.

Event Description

Catheter cracked at the connection of the line to the luer lock.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• MDR Report Key: 10656252
• MDR Text Key: 210641004
• Report Number: 2245270-2020-00091
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): Y
• PMA/PMN Number: : K921352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1270.03
• Device Catalogue Number: 1270.03
• Device Lot Number: 190719PA AND 260819PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1