PRESSURE MONITORING SET

Additional Manufacturer Narrative

THE DEVICE WILL NOT BE RETURNED FOR EVALUATION HOWEVER, A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE PRESSURE MONITORING KIT ON AN ADULT PATIENT, THE CONNECTION BETWEEN ZERO STOPCOCK AND VAMP FLEX BECAME DETACHED, AND SMALL AMOUNT OF BLOOD LEAKAGE WAS OBSERVED. THE DETACHED CONNECTION WAS IMMEDIATELY RECONNECTED AND THE DEVICE WAS CONTINUOUSLY USED WITHOUT REPLACEMENT. NO ADDITIONAL TREATMENT WAS REQUIRED DUE TO THIS EVENT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED AT THE HOSPITAL.