PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRA

Description of Event or Problem

IT WAS REPORTED THAT THE BLUE 15MM CONNECTOR KEPT DISCONNECTING FROM THE TRACHEAL TUBE. THE TIP WAS NOT DEEP ENOUGH INSIDE THE TUBE AND JUST DISCONNECTS. NO CLINICAL CONSEQUENCE, ISSUE OCCURRED UPON OPENING.

Additional Manufacturer Narrative

OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H10: DEVICE EVALUATION: THE SAMPLES CONSISTED OF 54 UNITS THAT WERE RETURNED FOR INVESTIGATION. THE RETURNED SAMPLES WERE RECEIVED IN UNUSED CONDITIONS WITHIN THE ORIGINAL PACKAGE. THE RETURNED SAMPLES WERE VISUALLY INSPECTED UNDER NORMAL CONDITIONS OF ILLUMINATION TO DETECT ANY CONDITION THAT COULD CAUSE THE FAILURE MODE REPORTED. PER VISUAL INSPECTION, CONNECTOR HAD PROPERLY ASSEMBLED INSIDE TUBE FOR 54 SAMPLES RECEIVED. BASED ON THE ANALYSIS CONDUCTED ON THE SAMPLES PROVIDED, THE CONNECTOR WAS DEEP ENOUGH INSIDE THE TUBE, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. NO OTHER ANALYSIS WAS PERFORMED. NO FAULT WAS FOUND WITH THE DEVICE AS THE REPORTED ISSUE/FAILURE MODE WAS NOT VERIFIED OR CONFIRMED. NO ROOT CAUSE WAS DETERMINED, AND NO CORRECTIVE ACTIONS WERE REQUIRED SINCE THE COMPLAINT WAS NOT CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10010579, AS A RESULT OF WARNING LETTER CMS# 617147.