GLP LOADER MODULE

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS PROVIDED, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT SERUM SPILLAGE OCCURRED ONTO HER FACE AND LAB COAT WHILE TROUBLESHOOTING A GRIPPER ERROR DISPLAYED ON THE ARCHIVE LOADER SCREEN OF THE GLP LOADER MODULE. UPON INVESTIGATION, THE ISSUE OCCURRED ON (B)(6) 2026, FEMALE, SID SNOW, WHO OBSERVED THAT FOUR TUBES STUCK TOGETHER IN THE DISPOSAL AREA. OF THE FOUR TUBES, TWO WERE ASSOCIATED WITH THE GRIPPER, WITH ONE TUBE PIERCED THROUGH THE GLP RECAP INTO ANOTHER TUBE AND THE SECOND TUBE BEING HELD BY THE GRIPPER. WHILE ATTEMPTING TO REMOVE THE TUBES, SERUM SPILLED ONTO THE OPERATOR'S FACE. THE CUSTOMER WAS WEARING A LAB COAT, AND APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE). THE CUSTOMER RINSED THE AFFECTED AREA WITH WATER. THE OPERATOR RECEIVED AN ANTIVIRAL FIRST DOSE & STARTED ON PROPHYLAXIS. THERE WAS NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT REPORTED. NO OTHER IMPACT TO USER WAS REPORTED. THE INDIVIDUAL WAS STARTED ON PROPHYLAXIS.