PORTEX

Additional Manufacturer Narrative

RETURNED DEVICE WAS RECEIVED FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE IT COULD BE CONFIRMED THAT THE BLUE FEMALE LUER SHOWS A CRACK. THE CUSTOMER REPORTED CONDITION WAS CONFIRMED. PROBLEM SOURCE IS UNKNOWN THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

Description of Event or Problem

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX THORACIC CATHETER WAS PUT IN PLACE FOR DRAINAGE OF A RIGHT PLEURAL EFFUSION. THE DRAIN HAD SUCCESSFULLY DRAINED 1200CC OF SEROUS FLUID OVER 12 HOURS. MANIPULATION OF THE DRAIN DRESSING WAS DONE TO ACCESS THE 3-WAY TAP. CONTINUOUS BUBBLING WAS NOTED TO THE DRAINAGE CASE FOLLOWING AND THE TUBING WAS THEN CLAMPED CLOSE TO THE PATIENT. THE BUBBLING CONTINUED, SO THE PATIENT WAS TAKEN TO RADIO CONTROL FOR REMOVAL. AFTER REMOVAL, THE FEMALE CONNECTOR PART WAS NOTED TO HAVE LEAKED AND WAS SPLIT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AS THE EFFUSION WAS OBSERVED TO BE WELL DRAINED.