PREFILLED FORMALIN CONTAINER

Additional Manufacturer Narrative

ON (B)(6) 2017, IT WAS REPORTED BY (B)(6) AT THE USER FACILITY THAT 2 PREFILLED CONTAINERS OUT OF THE CASE OF 256 RECEIVED WERE FOUND TO BE CRACKED. THE VIDEO FOOTAGE OF THE SHIPMENT PACKAGING AND PRODUCT QUALITY WAS REVIEWED AT THE TIME OF THE COMPLAINT IN ADDITIONAL TO A REVIEW OF ALL ON HAND MATERIAL. ALL EVIDENCE FOR THE SHIPMENT AND PRODUCT IN QUESTION INDICATES THAT IT WAS PROPERLY PACKED FOR SHIPMENT. NO ADDITIONAL INFORMATION WAS FOUND THAT INDICATED A DEVICE FAILURE OR MANUFACTURING ISSUE. THE PRODUCT WAS DELIVERED TO THE USER FACILITY ON (B)(6) 2017, HOWEVER THE REPORT OF DAMAGED CONTAINERS WAS NOT REPORTED UNTIL 07/27/2017. THE 2 RETURNED CONTAINERS HAD EVIDENCE OF WRITING ON THE LIDS, WHICH DOES NOT OCCUR PRIOR TO SHIPMENT, INDICATING THEY WERE HANDLED AT THE USER FACILITY, MOST LIKELY PRIOR TO DAMAGE. IT WAS OUR SUMMATION GIVEN THE FACTS PROVIDED THAT THE PRODUCT WAS EITHER DAMAGED DURING TRANSIT, THOUGH NO DAMAGE TO THE PACKAGE UPON ARRIVAL WAS REPORTED, OR DAMAGED AT THE USER FACILITY. THE COMPLAINT WAS LOGGED AND CLOSED AS AN UNJUSTIFIED COMPLAINT. GIVEN THAT THE REPORTER OF THE ISSUE INDICATED THAT THERE WAS NO NEGATIVE IMPACT TO PATIENT CARE, AND THE CONTAINERS NEVER CONTAINED A PATIENT SPECIMEN, NO ADDITIONAL ACTIONS WERE NECESSARY.

Description of Event or Problem

TWO PREFILLED FORMALIN SPECIMEN CUPS WERE NOTED TO BE BROKEN WITHOUT ANY FORMALIN IN THE CUP. NO PATIENT SPECIMEN WAS PLACED IN THE CUP. NEW SPECIMEN CUP WAS RETRIEVED AND PROCESSED WITH NO PROBLEM.