PORTEX
Received Aug 4, 2021
Report 3012307300-2021-08066 · MDR key 12277282
Product problems
- Product Quality Problem
- Product Quality Problem
Patient
Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WERE INK STAINS ON THE DEVICES.
Additional Manufacturer Narrative
OTHER, OTHER TEXT: ADDITIONAL INFORMATION ADDED TO H6 AND H10. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10010116, AS A RESULT OF WARNING LETTER CMS# 617147. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. BASED ON PICTURES PROVIDED IN COMPLAINT INVESTIGATION, AFTER IMAGES REVIEW INK STAINS INSIDE TUBE CAN BE OBSERVED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE OPERATOR MISHANDLING USING PRODUCTION EQUIPMENT. ACTIONS WERE TAKEN TO MITIGATE THE REPORTED ISSUE: A NOTIFICATION AWARENESS TO OPERATORS WERE ISSUED IN ORDER TO NOTIFY ALL PERSONNEL ABOUT ISSUE REPORTED WITH INK STAINS ON MANOMETER SURFACE.