HEALTH CARE TECHNOLOGY

Description of Event or Problem

CUSTOMER INDICATED THAT THE CENTRAL LINE KIT ARRIVED, WHERE THE SUPPLIES WERE PLACED ON THE BLUE"PART, WHICH MEANT THAT THE ITEMS WERE NOT ON A STERILE FIELD. HOWEVER, IT SHOULD BE NOTED THAT THE BOTH SIDES OF THE WRAP GO THROUGH THE STERILIZATION PROCESS (STRADIS STERILIZATION LOAD# M20104 AT (B)(6)) SO IN FACT THERE IS A STERILE FIELD STILL.

Additional Manufacturer Narrative

THE CUSTOMER COMPLAINT INDICATED NORMALLY ALL OF THE SUPPLIES ARE ON THE WHITE PART OF THE STERILE FIELD. 3/5 KITS YESTERDAY HAD SUPPLIES ON THE BLUE PART WHICH MEANT YOU DID NOT HAVE A STERILE FIELD. HOWEVER, DUE TO THE EO GAS STERILIZATION PROCESS, BOTH SIDES OF THE CSR WRAP ARE STERILIZED. UPON RECEIPT OF THE COMPLAINT, THE IMPACT TO THE PATIENT WAS ASSESSED AND DETERMINED TO BE A DELAY IN A ROUTINE PROCEDURE NOT A LIFE-SAVING EVENT. ADDITIONALLY, THE ISSUE WAS DETERMINED NOT TO ADVERSELY AFFECT THE STERILE BARRIER NOR THE STERILITY OF THE CONTENTS. THEREFORE WHILE THIS ISSUE MAY HAVE RESULTED IN A TREATMENT DELAY, IT DID NOT INCREASE THE PATIENT EXPOSURE TO NON-STERILE DEVICES. AS A RESULT OF THE REVIEW THIS WAS INVESTIGATED AS A CUSTOMER COMPLAINT. IT WAS DETERMINED NOT TO QUALIFY AS A MEDICAL DEVICE REPORTABLE EVENT. NOR DID THIS ASSESSMENT INDICATE THAT ADDITIONAL FIELD ACTIONS WERE REQUIRED. DURING THE INVESTIGATION, A REVIEW OF THE WORK INSTRUCTIONS WITH ASSEMBLER INDICATED THE INSTRUCTIONS RESULTED IN SOME CONFUSION INDICATING THE INSTRUCTIONS WERE AT THE ROOT AND MAY HAVE CONTRIBUTED TO QUALITY INSPECTORS FAILING TO DETECT THE ERRORS. THE WORK INSTRUCTIONS HAVE SINCE BEEN REVISED.