TRUWAVE

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE DEVICE HISTORY RECORD REVIEW HAS NOT YET BEEN 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 PRIOR TO USE ON PATIENT, THE PRESSURE MONITORING SETS WHITE CAP ATTACHED TO THE THREE-WAY STOPCOCK OF THIS MONITORING KIT DID NOT HAVE A HOLE WHICH SHOULD BE THERE AS VENTED CAP. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

ONE PRESSURE MONITORING SET WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT OF CAP DID NOT HAVE A HOLE WAS CONFIRMED. THE RECEIVED CAP WAS NON-VENTED. THE FINDINGS WERE ALIGNED TO THE CUSTOMER PHOTO. NO VISIBLE DAMAGE WAS OBSERVED FROM THE NON-VENTED CAP. DURING THE EXECUTION OF THE ENGINEERING EVALUATION PROCESS, IT WAS IDENTIFIED THAT THE DEVICE INVOLVED IS MANUFACTURED BY THE ELCAM MEDICAL SUPPLIER, THESE DEVICES ARE NOT PROCESSED INTERNALLY IN THE BD APM MANUFACTURING PROCESS, CONSEQUENTLY, THIS IS A SUPPLIER RELATED CONDITION, AND THE CORRESPONDING SUPPLIER NOTIFICATION WAS SENT DUE TO MAIL BY THE DR SUPPLIER QUALITY TEAM. DHR REVIEW WAS PERFORMED AND NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED ASSOCIATED WITH THE REPORTED MALFUNCTION.