FEEDING TUBE
Received Jun 30, 2020 · Event occurred Jun 20, 2020
Report 2245270-2020-00049 · MDR key 10213707
Product problems
- Material Too Rigid or Stiff
- Material Deformation
- Material Too Rigid or Stiff
- Material Deformation
Patient
0 YR
- No Known Impact Or Consequence To Patient
- No Information
- No Clinical Signs, Symptoms or Conditions
- No Known Impact Or Consequence To Patient
- No Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional 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.
Description of Event or Problem
6 FR PVC TUBES HARDENING DURING PATIENT DWELL.
Additional 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.
Description of Event or Problem
6 FR PVC TUBES HARDENING DURING PATIENT DWELL.