CARDINAL HEALTH

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED AN ISSUE THAT OCCURS QUITE FREQUENTLY IS THAT AFTER THE TUBE IS POSITIONED IN THE STOMACH, IT CAN BE EXTREMELY DIFFICULT TO WITHDRAW THE WIRE (STYLET). WHEN FORCE IS APPLIED, THE PURPLE CAP MAY DETACH, EXPOSING THE HOOKED WIRE UNDERNEATH. THIS CREATES A SAFETY RISK, AS THE EXPOSED WIRE CAN CAUSE CUTS IF NOT HANDLED CAREFULLY, AN INCIDENT THAT HAS ALREADY AFFECTED TWO OF THEIR RADIOLOGISTS. AS A RESULT, ONE RADIOLOGIST NOW REFUSES TO PULL ON THE CAP ALTOGETHER. INSTEAD, THEY HAVE TO USE A KELLY CLAMP TO REMOVE THE WIRE WHEN IT BECOMES STUCK, EVEN AFTER FLUSHING THE TUBE WITH WATER BEFOREHAND TO HELP LOOSEN IT. THE WIRE WAS TESTED PRIOR TO USE BY PULLING IT IN AND OUT OF THE TUBE. IN THIS INSTANCE THE STYLET WAS EVENTUALLY REMOVED BY PULLING VERY HARD AND USING A KELLY CLAMP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. PER FURTHER INFORMATION PROVIDED ON (B)(6) 2026, THE PURPLE CAP DID DETACH DURING THIS INCIDENT. HOWEVER, RADIOLOGISTS WERE NOT HARMED DURING THIS EVENT. THE MENTION OF TWO RADIOLOGIST WHO HAVE BEEN AFFECTED ARE REFERRING TO PRIOR INCIDENTS. THE HYDROMER COATING ON THE INNER DIAMETER OF THE TUBE WAS ACTIVATED BY INJECTING APPROXIMATELY 10 ML OF WATER PRIOR TO PATIENT INSERTION AND WAS REACTIVATED WITH 10ML OF WATER AFTER PLACEMENT.