TRUWAVE

Additional Manufacturer Narrative

ONE SINGLE DPT - VAMP PLUS KIT WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT OF FOREIGN MATERIAL INSIDE THE TUBING WAS CONFIRMED. AN UNKNOWN DARK BROWN PARTICULATE, APPROXIMATELY 5.5CM CM DISTAL FROM PROXIMAL SAMPLING SITE WAS OBSERVED INSIDE PRESSURE TUBING. THE PARTICULATE WAS APPROXIMATELY 2MM X 5MM, ATTACHED TO THE INNER WALL OF PRESSURE TUBING. THE PARTICULATE STAYED AT THE SAME LOCATION ON PRESSURE TUBING AFTER 5 MINUTES OF CONTINUOUS FLUSHING. A CHEMISTRY ANALYSIS WAS PERFORMED ON THE PARTICULATE HOWEVER, THE IR SPECTRUM ANALYSIS OF THE PARTICULATE WAS INCONCLUSIVE SINCE ABSORPTION CHARACTERISTICS WERE SIMILAR TO VARIOUS MATERIALS. AN ENGINEERING EVALUATION WAS THEN INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. DURING THE EXECUTION OF THE ENGINEERING EVALUATION PROCESS, IT WAS IDENTIFIED THAT THE INVOLVED DEVICE IS MANUFACTURED BY INFUS, A THIRD PARTY MANUFACTURER. THESE DEVICES ARE NOT PROCESSED INTERNALLY IN THE BD APM MANUFACTURING PROCESS. THE INFUS INVESTIGATION CONCLUDED THAT THE EVENT COULD BE RELATED TO THEIR MANUFACTURING PROCESS. FROM REVIEWING THE COMPLAINT DESCRIPTION AND PHOTOS, THE BROWN MATERIAL COULD BE THE BURNT PVC MATERIAL IN THE TUBE, AND IT WAS NOT DETECTED DURING THE INSPECTION. THEREFORE BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A BD APM MANUFACTURING OR DESIGN DEFECT. AS PART OF THE MANUFACTURING PROCESS 100% OF THE UNITS GO THROUGH A BD APM VISUAL INSPECTION. THE DEVICE HISTORY RECORD REVIEW WAS ALSO PERFORMED AND THE PRODUCT PASSED WITHOUT NONCONFORMANCES.

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. 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 BEFORE USE IN PATIENT, A LINT BALL LIKE FOREIGN MATERIAL WAS FOUND INSIDE THE TUBING OF THIS PRESSURE MONITORING KIT. THE PACKAGING WAS OPENED. THERE WAS NO ALLEGATION OF PATIENT INJURY.