MalfunctionKDH
LUKI ASP TUBES 61/4
Received Aug 20, 2019 · Event occurred Aug 15, 2019
Report 1282497-2019-08612 · MDR key 8910902
Device
Generic name
Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration
Manufacturer
CovidienModel number
8886864604Catalog number
8886864604
Lot number
182110004
Product problems
- Crack
- Degraded
- Crack
- Degraded
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE DEVICE HAD A EXTREMELY DRY TUBING THAT WAS CRACKING.