PORTEX DISPOSABLE MANOMETER
Received Feb 15, 2022
Report 3012307300-2022-03434 · MDR key 13537500
Device
Product problems
- Product Quality Problem
- Product Quality Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MULTIPLE PHOTOGRAPHS OF THE MANOMETER WERE PROVIDED IN SUPPORT OF THE INVESTIGATION. IT WAS CONFIRMED THAT THERE WERE INK STAINS PRESENT ON THE OUTSIDE OF THE MANOMETER. WHICH ARE NOT IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO THE MISHANDLING OF THE DEVICE DURING THE MANUFACTURING PROCESS, RESULTING IN INK STAINS ON THE OUTSIDE OF THE MANOMETER. TO ADDRESS THE ISSUE, A NOTIFICATION WAS PROVIDED TO ALL MANUFACTURING OPERATORS TO NOTIFY REGARDING THIS ISSUE, AND A (B)(6) IMPLEMENTATION IN THE MACHINE FIXTURE TO PREVENT THE ISSUE FROM OCCURRING. A DHR REVIEW WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW.
Description of Event or Problem
IT WAS REPORTED THAT THERE ARE INK STAINS ON THE SURFACE OF THE NANOMETER. THERE WAS NO PATIENT INVOLVEMENT REPORTED.