Description of Event or Problem · 1
DISCREPANCY IN STERILITY OF PRODUCT. INNER PRODUCT AND BOX LABELED SAME, STICKERS INSIDE PRODUCT LABELED WITH DIFFERENT EXPIRATION DATE. VENDOR ONLY BROUGHT ONE OF THE SIZE FOR SURGEON FOR PROCEDURE. PATIENT ON OPERATING ROOM TABLE WHEN DISCOVERED. PRODUCT: OSTEOBRIDGE NAIL WITH COLLAR REF # GA11620, LOT # MS1304612 OUTER BOX EXPIRATION DATE 2018-11; INNER STERILE PEEL PACKAGE EXPIRATION DATE 2018-11, STICKERS TO BE USED ON PATIENT CHART DATED EXPIRATION DATE 2013-11. VENDOR UNABLE TO VALIDATE STERILIZATION INTEGRITY PRIOR TO USE IN PATIENT. VENDOR CALLED (B)(6) TO OBTAIN STERILIZATION AND QUALITY CONTROL INFORMATION. HOSPITAL RECEIVED EMAIL FROM (B)(6) STATING "AFTER CHECK OUR PRODUCTION DOCUMENTS, WE CAN CONFIRM THE STERILITY OF THE PRODUCT GA11620, LOT: MS1304612, UNTIL 2018-11." NO OTHER DOCUMENTATION PROVIDED BY VENDOR. EVENT REPORTED TO HOSPITAL RISK MANAGEMENT AND INFECTION CONTROL.