PVC - PORTEX TUBES BLUE LINE CLASSIC

Additional Manufacturer Narrative

OTHER, OTHER TEXT: ADDITIONAL INFORMATION: G5 IS UNKNOWN. NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. ONE SAMPLE WAS RECEIVED IN USED CONDITIONS, WITHOUT THEIR ORIGINAL PACKAGING, DECONTAMINATED AND INSIDE A PLASTIC BAG. PICTURE 1: THE RETURNED SAMPLE WAS VISUALLY INSPECTED AT 12 TO 16 INCHES AND NORMAL CONDITIONS OF ILLUMINATION. PER VISUAL INSPECTION, THE SAMPLE WAS MANIPULATED AND RETURNED WITH INCOMPLETE ASSEMBLY. IT WAS RECEIVED ONLY THE FLANGE COMPONENT AND IT CAN BE SEEN THAT THE FLANGE WAS USED SINCE IT WAS ALREADY CURVED AND NOT PLANE. PICTURE 2: PER VISUAL INSPECTION A CRACK WAS IN THE FLANGE RETURNED, ALONG THE MOLDING INJECTION POINT. PICTURE 3 AND 4: IT APPEARED THEY TRIED TO REPLICATE THE FAILURE MODE BY APPLYING EXCESSIVE FORCE TO A FLANGE IN ORDER TO SEE IF IT CRACKS. PER PICTURE 5, IT WAS NOT POSSIBLE TO REPLICATE THE CRACK. THE PIECE DID NOT BROKE IN ASSEMBLY MANUFACTURING PROCESS SINCE THE CUSTOMER RECEIVED AND USED IT AND BROKE DURING USE, THEREFORE IT IS NOT MANUFACTURING ASSEMBLY RELATED, THE MOST PROBABLY ROOT CAUSE WAS THE MOLDED PIECE CAME WEAK SINCE IT BROKE ALONGSIDE THE MOLDING INJECTION POINT ALL MITIGATIONS ON THE MANUFACTURING WERE VERIFIED AND IT WAS CONFIRMED THAT IT HAS BEEN EXECUTED ACCORDINGLY, THEREFORE NO CORRECTIVE ACTIONS COULD BE IMPLEMENTED. CONTINUE MONITORING OF THIS FAILURE CONDITION IN THIS PRODUCT FOR THRESHOLD OR ESCALATION.

Description of Event or Problem

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE CANNULA FIXATOR BROKE AND IT WAS NECESSARY TO OPEN ANOTHER CANNULA. THERE WERE NO REPORTED ADVERSE EVENTS.