PORTEX TUBES BLUSELECT

Description of Event or Problem

IT WAS REPORTED THAT TWENTY-EIGHT (28) DAYS AFTER STARTING TO USE THE PRODUCT, THE CUSTOMER NOTICED THE INFLATION LINE WAS DETACHED FROM THE PILOT BALLOON. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. ONE USED DECONTAMINATED SAMPLE 10009163-002 7MM DEHT BLU SUCTIONAID SUB-ASSY WAS RETURNED FOR INVESTIGATION WITHOUT ITS ORIGINAL PACKAGING. UNDER VISUAL INSPECTION WE NOTICED THAT INFLATION LINE WAS DETACHED FROM PILOT BALLOON. SIMILAR CUSTOMER COMPLAINTS HAVE BEEN RECENTLY RECEIVED THEREFORE INTERNAL NON-CONFORMITY REPORT NCR-000928 WAS CREATED WITH PURPOSE TO EVALUATE THIS ISSUE. THE ANALYSIS PERFORMED IN THE SAMPLE RECEIVED CONCLUDED THAT THE OCCURRENCE OF THIS FAILURE CONDITION COULD BE CAUSED BY: NOT ENOUGH THF SOLVENT AT JOINT CAUSE BY BAD CONDITION ON THE THF FEEDER SYSTEM EQUIPMENT. THE CAUSE OF THE REPORTED PROBLEM WAS TRACED TO THE MANUFACTURING PROCESS. ANY RELEVANT DMRS, NCRS, ETS: THERE NO RELEVANT NON-CONFORMANCE (NCR'S) OR ENGINEERING TEST (ET) FOR THIS LOT.