CARDINAL HEALTH S/P ORANGE 50G GLUCOSE TOLERANCE

Description of Event or Problem

IN 2008, PATIENT WAS ADMINISTERED DOSAGE OF CARDINAL HEALTH S/P ORANGE 50G GLUCOSE TOLERANCE BEVERAGE. PATIENT DRANK BEVERAGE DIRECTLY OUT OF GLASS BOTTLE; PATIENT'S TONGUE CAME INTO CONTACT WITH A PIECE OF GLASS AND NOTICED BLOOD. PATIENT SPIT PIECE OF GLASS BACK INTO BOTTLE. MANUFACTURER WAS MADE AWARE OF THIS EVENT ON 4/8/2008.

Additional Manufacturer Narrative

IN RESPONSE TO THE RECEIPT OF THIS CUSTOMER COMPLAINT, WE RETRIEVED THE BOTTLE FROM THE FACILITY INVOLVED WITH THE PATIENT AND CONDUCTED A RISK ASSESSEMENT. WE DECIDED TO RECALL THE ENTIRE LOT OF PRODUCT WHICH WAS SHIPPED TO ONE DISTRIBUTOR. WE ARE WORKING WITH THAT DISTRIBUTOR IN ORDER TO ENSURE THAT ALL END USERS ARE NOTIFIED OF THE RECALL. IN ADDITION, TO ENSURE THAT THE PRODUCT REMAINS FREE OF PARTICULATE MATERIAL (BROKEN GLASS), OUR REGULATORY AFFAIRS AND OPERATIONS STAFF VISITED THE SITE TO CONDUCT AN ASSESSMENT OF FILL-LINE TO DETERMINE IF ANY ADDITIONAL PREVENTATIVE ACTIONS COULD BE IMPLEMENTED. SPECIFICALLY, WER REVIEWED THIS EVENT WITH THE ENTIRE PRODUCTION STAFF AS AN AWARENESS FOLLOW UP AND CONDUCTED A COMPLETE REVIEW, FILLER CLEANING PROCEDURE FOR BROKEN BOTTLES, AND REVIEWED LINE GUARDING PROCEDURES FOR GLASS BOTTLES. WE UPDATED THE SOP TO INCLUDE CHECKING THE BOTTLE SEAT AREA FOR ANY BROKEN GLASS DURING AN EVENT AND DECIDED TO INCREASE THE NUMBER OF BOTTLES DISCARDED IN THE EVENT OF A BROKEN BOTTLE DURING THE FILL. WE ALSO WILL ADD ADDITIONAL EMERGENCY E-STOP SWITCHES TO ALLOW THE OPERATOR TO SHUT-DOWN THE LINE IN A MORE TIMELY MANNER BY 05/21/2008. FINALLY WE HAVE QUARANTINED OTHER UNRELATED LOTS OF PRODUCT IN ORDER TO CONDUCT RANDOM TESTING TO ENSURE THAT NO PARTICULATE MATTER EXISTS IN THOSE LOTS. WE BELIEVE THAT THIS OCCURRENCE IS AN ISOLATED EVENT.