Description of Event or Problem · 1
AT THE TIME OF THE SURGERY, CIRCULATING NURSE REQUESTED EXPIRATION DATE INFORMATION FROM THE DEVICE REP. AFTER THE IMPLANT WAS INSERTED, AND AFTER THE PROCEDURE, THE REP. PRESENTED A BOX IN WHICH THE IMPLANT WAS TAKEN. THE NURSE COMPARED THE PEEL-PACK LABEL AND THE BOX LABEL AND COULD NOT DETERMINE AN EXPIRATION DATE. SHE QUESTIONED THE CHARGE NURSE WHO TOOK A PICTURE OF THE PEEL PACK LABEL AND SAW AFTER ZOOMING THAT THERE WAS AN ICON ON THE LABEL WITH TINY NEAR ILLEGIBLE PRINT "NON-STERILE". THE CHARGE NURSE IMMEDIATELY NOTIFIED SENIOR LEADERSHIP AND RISK MANAGEMENT. THE SURGEON WAS NOTIFIED AND TOOK A LIST OF TEN PATIENT NAMES WHO HAD RECEIVED THE SAME TYPE OF IMPLANT. THROUGH CAREFUL INVESTIGATION, IT HAS BEEN DETERMINED THAT FIVE OF THESE IMPLANTS WERE INSERTED AFTER BEING STERILIZED THROUGH THE HOSPITAL'S CENTRAL STERILIZATION DEPARTMENT (CSD). THE CSD STAFF REPORT THAT THE DEVICE REP. HANDED THEM THE DEVICES ON THOSE OCCASIONS. THESE WERE NOT IN A PEEL-PACK OR OTHER TYPE OF PACKAGING. THE OTHER FIVE IMPLANTS WERE EVIDENTLY INSERTED DIRECTLY FROM THE MANUFACTURER'S PACKAGING LABELED AS NON-STERILE. OR DIRECTOR REVIEWED THE LABELING OF THE OTHER IMPLANTS AS WELL AS THE EMPTY PACKAGING FOR DEVICES THAT WERE INSERTED. IT WAS FOUND THAT ALL THE PACKAGING HAD THE SMALL ICON "NON-STERILE" THAT WAS UNABLE TO BE READ WITHOUT MAGNIFICATION. IT WAS FOUND THAT THERE ARE MANUFACTURING DATES OF THE DEVICES PRINTED AS JULY 2013, AND APRIL 2024. THE INVESTIGATION ALSO PRODUCED THE FDA APPROVAL LETTER DATED JUNE 13, 2018. THE PACKAGING OF SOME OF THE DEVICES HAD MULTIPLE LABELS ON TOP OF EACH OTHER. THE PEEL PACK LABEL ALSO INCLUDES PEEL-OFF STICKERS WITH SERIAL NUMBER, LOT NUMBER, TO BE USED FOR DOCUMENTATION. THESE LABELS WERE NOT AVAILABLE ON THE ABOVE-MENTIONED IMPLANTS THAT WERE STERILIZED THROUGH SPD (STERILE PROCESSING DEPARTMENT).