FLUTED F.D 10MM WHITE (HUB) STERILE

Additional Manufacturer Narrative

THERE WERE NO NON-CONFORMITIES DETECTED DURING THE BATCH HISTORY REVIEW AND TESTING OF THE RETAIN SAMPLE. THE DRAIN COULD TEAR DUE TO DAMAGE IN USE. THE COMPLAINT CONSIDERED TO BE NOT JUSTIFIED; NO CAPA IS REQUIRED IN THIS CASE.

Description of Event or Problem

THE DRAIN HAS COME APART IN THE TUBE-WHITE PROFILE CONNECTION. THIS HAS CAUSED A LONGER OPERATION AND ALSO A RE-OPERATION ON ANOTHER PATIENT. AS PER CUSTOMER THERE WAS NO INJURY REPORTED. THE DRAIN BROKE INSIDE THE PATIENT WHILE THEY WERE ATTEMPTING TO REMOVE IT FROM THE PATIENT. AN ADDITIONAL SURGERY WAS DONE TO REMOVE THE BROKEN DRAIN WHICH LASTED FOR 15 MINUTES. PATIENT IS DOING WELL.