D
Patient 1
SITE VALVE CRACKED ON PT'S CENTRAL LINE LUMEN. EXPERIENCING PROBLEMS WITH RYMED ((B)(4)) CONNECTORS. THEY ARE BREAKING OFF IN THE TUBING AND NURSES ARE FINDING THE BROKEN TUBING WHEN THEY ASSESS THE PTS. THERE WERE 5 INSTANCES OF THIS IN (B)(6), WITH LOT NUMBERS RO1857 AND RO1839. ALL OF THE CONNECTORS THAT WERE BROKEN IN THOSE LOTS WERE SHIPPED TO (B)(6) FOR TESTING. THE PROCESS TAKES A LITTLE OVER A WEEK. THEIR QA DEPT FOUND NOTHING WRONG WITH THE CONNECTORS. IN THE INTERIM, LOT NUMBER RO1860 WAS DELIVERED AT THE FIRST OF (B)(6). SINCE THEN, THREE REPORTABLE INSTANCES OF CONNECTORS BREAKING HAVE OCCURRED. TWO OF THOSE THREE BROKEN CONNECTORS WILL ALSO BE SENT TO (B)(6) FOR TESTING (THE OTHER WAS NOT AVAILABLE). OUR FACILITY HAS CARRIED THE RYMED CONNECTORS FOR ROUGHLY FOUR YEARS AND UNTIL NOW, HAS NEVER SEEN A RUSH OF INSTANCES LIKE THESE. THE RYMED SALES REP WAS CONTACTED AND WE ARE TOLD THE CONNECTORS NEEDED TO BE CHANGED EVERY 24 HOURS, WHICH WAS UNCLEAR TO OUT FACILITY UNTIL THEN. WE ARE WORKING ON A PROCESS TO PUT THIS ACTION INTO PLACE. SEE MW5042740-MW5042744 AND MW5042746.