PORTEX® SELDINGER CHEST DRAINAGE KIT

Description of Event or Problem

INFORMATION WAS RECEIVED INDICATING THAT AN AIR FISTULA WAS DETECTED LEADING TO LEAKING OF THE SMITHS MEDICAL PORTEX® SELDINGER CHEST DRAINAGE SYSTEM. THE DRAIN WAS REMOVED AS THE LEAK WAS UNABLE TO BE FOUND. UPON VISUAL EXAMINATION OF THE DRAIN, A 1 CM LONG LONGITUDINAL CRACK WAS NOTED AT THE SCREW ATTACHMENT OF THE DRAIN. IT WAS REPORTED THAT THE DRAINAGE SYSTEM WAS NOT REMOVING CEREBRAL SPINAL FLUID (CSF) AS IT WAS SUPPOSED TO BUT AFTER THE SYSTEM CHANGE OUT, 100MLS OF CSF DRAINED. THERE WERE NO REPORTED ADVERSE EFFECTS.

Additional Manufacturer Narrative

EVALUATION RESULTS: ONE USED PLEURAL CATHETER WAS RETURNED FOR INVESTIGATION. THE INVESTIGATORS CONFIRMED THE CUSTOMER REPORTED PROBLEM REGARDING THE 1 CM LONG LONGITUDINAL CRACK AT THE SCREW ATTACHMENT OF THE DRAIN. 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. THE INVESTIGATORS CONCLUDED THAT THE INCIDENT WAS NOT DUE TO A PRODUCT FAILURE. AN EXACT ROOT CAUSE FOR THE REPORTED FAILURE WAS NOT DETERMINED HOWEVER.