MAUDE Adverse Event Report: VYGON FEEDING TUBE

Model Number 361.062

Device Problems Material Too Rigid or Stiff (1544); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2020

Event Type  malfunction  

Manufacturer Narrative

The failed 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

6 fr pvc tubes hardening during patient dwell.

Manufacturer Narrative

10.[x] additional manufacturer narrative and/or 11.[ ] corrected data.There were 2 occurrences of this issue, the details for the events can be found in the following reports: 2245270-2020-00049; 2245270-2020-00054.The complaint was forwarded to our parent company in france for their evaluation.The investigation summary is as follows: analysis of the samples revealed hardening of the distal end.This is a well-known phenomenon of pvc tubes which may happen with gastric fluids, depending on patients.Nevertheless, it happens very rarely.For this patient, we recommend switching to -pur- polyurethane feeding tube.Since no batch number was provided, it was not possible to review the batch history records.The composition of the product has not changed.We also do not have a record of similar claims in the past 3 years.Corrective action.Vygon france recommends switching to -pur- polyurethane feeding tube.No further corrective /preventive action is initiated at this time.However, both vygon usa and france will continue to monitor this issue.

Event Description

6 fr pvc tubes hardening during patient dwell.

• Brand Name: FEEDING TUBE
• Type of Device: FEEDING TUBE
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• MDR Report Key: 10213707
• MDR Text Key: 197743502
• Report Number: 2245270-2020-00049
• Device Sequence Number: 1
• Product Code: FPS
• Combination Product (y/n): N
• PMA/PMN Number: K060944
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 361.062
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Date Manufacturer Received: 06/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1