ARGYLE
Received Jul 24, 2017
Report 1282497-2017-05237 · MDR key 6735330
Device
Generic name
Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration
Manufacturer
CovidienModel number
8888750018Catalog number
8888750018
Lot number
162810001
Product problems
- Kinked
- Kinked
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
THE CUSTOMER STATES THAT THE EDLICH GASTRIC LAVAGE TUBE WAS BENT AND CRIMPED.
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER, SHOWS EVIDENCE THAT THE PRODUCT WAS RELEASED ACCORDING TO ALL ESTABLISHED PROCEDURES AND QUALITY ASSURANCE. ONE SAMPLE IN ITS ORIGINAL PACKAGE WAS RECEIVED. A VISUAL INSPECTION WAS PERFORMED AND KINKED TUBING WAS OBSERVED. THE FAILURE MODE WAS CONFIRMED. A FORMAL CORRECTIVE AND PREVENTATIVE ACTION INVESTIGATION WAS OPENED TO ADDRESS THE REPORTED ISSUE. THE PROCESS HAS BEEN UPDATED AND TRAINING HAS BEEN PERFORMED TO PREVENT KINKED TUBES DURING MANUFACTURING. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.