TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

CORRECTED SECTIONS D7A (SINGLE USE DEVICE REPROCESSED AND REUSED), E1 (REPORTER ADDRESS CITY AND PROVINCE), G2 (REPORT SOURCE, OTHER - CHINA) UPDATED SECTION H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS). THE REPORT OF "POUCH NOT SEALED" WAS UNABLE TO BE CONFIRMED THROUGH THE PRODUCT EVALUATION, AS THE TYVEK POUCH WAS NOT RETURNED. AS RECEIVED, ALL CONNECTIONS WERE TIGHT AND SECURE. THE KIT WAS PRIMED AND FLUSHED WITHOUT ANY INDICATION OF FLOW RESTRICTION. NO LEAKAGE WAS DETECTED DURING LEAK TEST. THE DPT (DISPOSABLE PRESSURE TRANSDUCER) SENSOR ALSO ZEROED AND SENSED PRESSURE WITHOUT ANY PROBLEM. NO VISIBLE DAMAGE/DEFECT WAS OBSERVED FROM THE KIT DURING VISUAL EXAMINATION. THE MANUFACTURING RECORDS WERE REVIEWED FOR THE LOT INVOLVED AND THERE IS NO INDICATION OF A RELATED NONCONFORMANCE. ALL PROCESS PARAMETERS WERE MET AND INSPECTIONS PASSED SUCCESSFULLY. THERE ARE INTERNAL CONTROLS DURING THE MANUFACTURING PROCESS TO AVOID POTENTIAL CAUSES RELATED TO THE REPORTED MALFUNCTION, SUCH AS 100% VISUAL INSPECTION.

Description of Event or Problem

AS REPORTED, BEFORE USING THIS PRESSURE MONITORING SET, IT WAS FOUND THAT THE POUCH WAS NOT SEALED AND DID NOT MEET STERILE STANDARDS, THEREFORE, IT WAS REPLACED. NO PICTURE IS AVAILABLE. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

Additional Manufacturer Narrative

THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. 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 PART OF THIS MONTHLY REVIEW.