PVC - PORTEX TUBES BLUE LINE CLASSIC

Description of Event or Problem

IT WAS REPORTED WHEN PUTTING AIR IN THE CUFF DURING THE PRE-USE CHECK, THE CUSTOMER NOTICED IT WAS INFLATED INSUFFICIENTLY. THE CUSTOMER MADE SEVERAL ATTEMPTS, BUT THE CUFF WAS NOT INFLATED ADEQUATELY. NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

OTHER, OTHER TEXT: 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# 617147. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW. FOUR (4) PICTURES WERE ATTACHED, DURING THE ANALYSIS CONDUCTED IT COULD BE OBSERVED THE DEVICE IN FIRST PICTURE, THEN A FOCUS ON CUFF AND PILOT BALLOON IN ONE OF THEM BOTH ARE INFLATED, HOWEVER IN THE SECOND IT CAN BE OBSERVED INFLATED ONLY THE PILOT BALLOON; LAST PICTURE SHOWS A FOCUS OF THE INFLATION LINE. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AT 12 TO 16 INCHES AND NORMAL CONDITIONS OF ILLUMINATION ACCORDING, INSPECTION PROCEDURE. PER VISUAL INSPECTION, NO DAMAGE WAS FOUND ON THE COMPONENTS, NO CONTAMINATION, NO FAILURE MODE CONDITIONS WERE OBSERVED, THE SAMPLE MET ALL THE SPECIFICATIONS. THE CUFF AND BALLOON PILOT OF THE SAMPLE RECEIVED WAS INFLATED ACCORDING THE RECOMMENDATIONS ON INFORMATION FOR USE (IFU) WITH AIR USING A SYRINGE IN ORDER TO EVALUATE THE CUFF. THE CUFF AND PILOT BALLOON OF THE SAMPLE COULD BE INFLATED WITHOUT LOOSING AIR. THE COMPLAINT IS NOT CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONFIRMED AS THE REPORTED ISSUE COULD NOT BE REPLICATED AT THE TIME OF THE DEVICE EVALUATION. NO CORRECTIVE ACTIONS ARE REQUIRED SINCE THE COMPLAINT FOR THE PHYSICAL SAMPLE PROVIDED WAS NOT CONFIRMED.