PORTEX THORACIC CATHETERS

Description of Event or Problem

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX THORACIC CATHETER WAS INSERTED INTO A PATIENT. AFTER INSERTION, A WHISTLING SOUND WAS HEARD AND EXPELLING OUT OF THE DRAIN. SUBSEQUENTLY, THE DRAIN WAS REMOVED AND REPLACED WITH ANOTHER WITH NO FURTHER ISSUE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

Additional Manufacturer Narrative

DEVICE EVALUATION: ONE DECONTAMINATED 007/910/280 (CATHETER PLEURAL SUB-ASSEMBLY) WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION SHOWED A CRACK ON THE BLUE FEMALE LUER CONNECTOR. THIS CRACK MAY HAVE POTENTIALLY CAUSED THE WHISTLING SOUND AND LEAK. A REVIEW OF MANUFACTURING PROCESSES WAS PERFORMED. IT WAS VERIFIED THAT PROCEDURES IN THE ASSEMBLY PROCESS AND QUALITY CHECK PROCESS WERE BEING PROPERLY FOLLOWED. THE ROOT CAUSE FOR THIS EVENT COULD NOT BE DEFINITELY DETERMINED. ONE POSSIBLE, BUT UNCONFIRMED, PROBLEM SOURCE WAS LISTED AS AN INCOMPATIBILITY OF THE PLEURAL CATHETER WITH COMPONENTS FROM OTHER SUPPLIERS CAUSING THE CRACK DURING THE CONNECTION PROCESS. THE INSTRUCTIONS FOR USE (IFU)WHICH IS SUPPLIED WITH THE SET PROVIDES CLEAR INSTRUCTIONS HOW THE COMPONENTS SHALL BE USED. THE IFU STATES IT IS THE RESPONSIBILITY OF THE USER TO CHECK THE COMPATIBILITY OF THE CHEST DRAINAGE KIT WITH PRODUCTS FROM OTHER SUPPLIERS.