Description of Event or Problem · 1
OPENING STERILE PACKAGE AND FOUND HUMAN HAIR IN IT.======================MANUFACTURER RESPONSE FOR LAP BRONCH MAJOR PROCEDURE PACKAGE, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================REGARDING: PRODUCT QUALITY REPORT NUMBER: CATALOG NUMBER: SBA32GPSPR.PRODUCT DESCRIPTION: MAJOR PROCEDURE PACK.LOT NUMBER: 951358.ISSUE: IT WAS FOUND A HAIR IN THE PACK.DEAR X:THE ABOVE COMPLAINT IS AN ISSUE THAT CARDINAL HEALTH PRESOURCE HAS BEEN CHALLENGED TO IMPROVE ON AN ONGOING BASIS. EVEN WITH SAMPLE EVIDENCE AVAILABLE, THE ROOT CAUSE FOR HAIR CONTAMINATION IS NOT ALWAYS OBVIOUS. SOME OF THE PRECAUTIONS WE TAKE INCLUDE:ASSEMBLING KITS IN A CLEAN ROOM ENVIRONMENT WITH FILTERED VENTILATION AND NO DIRECT ACCESS TO THE OUTDOORS. ALSO REQUIRING ALL OPERATORS TO WASH HANDS BEFORE ENTERING THE ROOM, DRESS IN FULL LENGTH GOWNS, AND WEAR HEAD-TO-NECK HAIR COVERS. DAILY AUDITS ARE PERFORMED TO ENSURE OPERATORS COMPLY WITH THE DRESS CODE PROCEDURES.USING PREP STATIONS TO REMOVE ALL ITEMS FROM PACKAGING BEFORE TRANSFER FROM WAREHOUSE, REDUCING THE AMOUNT OF CONTAMINANTS ENTERING THE CLEAN ROOM.ADDING REQUIREMENTS TO THE ASSEMBLY INSTRUCTIONS TO INSPECT AND CLEAN COMPONENTS BEFORE PLACING IN THE PACK.WORKING WITH SUPPLIERS TO ELIMINATE THE CONTAMINATION FOUND ON THEIR COMPONENTS.ALTHOUGH WE HAVE MADE MANY IMPROVEMENTS THROUGHOUT THE PROCESS, THERE ARE ALWAYS OPPORTUNITIES FOR US TO IMPROVE. WE WILL CONTINUE TO REVIEW OUR PROCEDURES AND PROCESSES AS PART OF OUR CONTINUOUS IMPROVEMENT EFFORTS.A REVIEW OF ANY AVAILABLE SAMPLE WILL BE PERFORMED PRIOR TO CLOSURE IN AN EFFORT TO DETERMINE A ROOT CAUSE FOR THIS DEFECT.SHOULD OUR ANALYSIS DETERMINE A ROOT CAUSE, FURTHER ACTION AND FOLLOW UP WILL BE TAKEN AS NEEDED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.