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Patient 1
THIS IS ONE OF THREE OCCURRENCES (ALL FROM SAME LOT) REPORTED ON THIS DAY WHERE STAFF OPENED A PACKAGE OF TUBING IN PREPARATION FOR AN ENDOSCOPY PROCEDURE. UPON OPENING THE PACKAGE AND BEFORE IT WAS USED, THE RN NOTICED THAT THE TUBING WAS CRACKED AND ALMOST COMPLETELY SEPARATED FROM THE CAP. WE HAVE SEEN THIS PROBLEM IN THE RECENT PAST AND CONTINUE TO BE IN CONTACT WITH THE MANUFACTURER'S REPRESENTATIVE. MULTIPLE LOTS HAVE BEEN AFFECTED. THE PRODUCT IS STORED IN A CABINET ON THE ENDOSCOPY UNIT. THE PRODUCT REMAINS IN ITS ORIGINAL BOX UNTIL IT IS NEEDED FOR A CASE. THIS IS THE ONLY PRODUCT STORED IN THAT CABINET. THE PRODUCT COMES FROM THE MANUFACTURER VIA THE MANUFACTURER'S DISTRIBUTOR. WHEN IT ARRIVES AT THE HOSPITAL, IT COMES THROUGH OUR RECEIVING DOCK AND THEN GOES DIRECTLY TO ENDOSCOPY. THE DEVICE IS NOT EXPOSED TO TEMPERATURE EXTREMES (HEAT OR COLD) DURING SHIPPING, RECEIVING, OR STORAGE. THE REP TOLD THE STAFF THAT THE MANUFACTURER HAS HAD SEVERAL FACILITIES COMPLAINING OF THE SAME FINDINGS-CRACKED TUBING UPON OPENING THE PACKAGING. THE MANUFACTURER BELIEVES THAT THE CRACKS ARE RELATED DIRECTLY TO THE WAY THAT THE DEVICE IS PACKAGED IN THAT THE TUBING IS WOUND TOO TIGHTLY. IT IS UNKNOWN WHY THE TUBING IS CRACKED UPON OPENING THE PACKAGE. STAFF IS FRUSTRATED IN THAT THEY ARE OPENING MULTIPLE PACKAGES BEFORE THEY CAN FIND ONE THAT IS NOT CRACKED. THE UNCRACKED TUBING IS FROM THE SAME LOTS AS THOSE THAT ARE CRACKED. THERE DOES NOT APPEAR TO BE A PATTERN IN THE LOT NUMBERS FOR CRACKED VERSES UNCRACKED TUBING.ENDOSCOPY STAFF NOTIFIED THE MANUFACTURER'S REP OF THE EVENT.