RECONSTITUTION ACCESSORIES

Additional Manufacturer Narrative

(B)(4). FOUR (4) UNUSED, UNOPENED SAMPLES, IN PACKAGING INDICATING THE REPORTED LOT # 0061385505, WERE RECEIVED FOR EVALUATION. UPON VISUAL OBSERVATION, THE PAPER BACKING OF THE BLISTER PACKAGE WAS NOTED TO BE TORN/RIPPED ON ALL FOUR SAMPLES. THE TEARS WERE ALL NEAR THE MIDDLE OF THE PACKAGE. DUE TO THIS ISSUE, THE PACKAGING LINE FOR THIS PRODUCT WAS INSPECTED AND REVIEWED. THE CURRENT BOX SIZE AND PACKAGING CONFIGURATION WAS VALIDATED AND FOUND TO BE SUFFICIENT FOR THIS PRODUCT. THERE HAVE BEEN NO CHANGES TO THE PACKAGING CONFIGURATION OR BLISTER SIZE SINCE. THIS BLISTER PACKED PRODUCT IS SHIPPED TO A WHOLESALE MEDICAL DISTRIBUTION COMPANY, WHERE IT IS PACKAGED INTO A KIT. SINCE THE REPORTED ISSUE WAS OBSERVED AT THE END USER FACILITY, IT COULD NOT BE DEFINITIVELY DETERMINED WHERE IN THE PACKAGING/SHIPPING/HANDLING PROCESS THIS ISSUE OCCURRED. ALTHOUGH OUR PACKAGING IS TESTED TO ASTM STANDARDS DURING DEVELOPMENT TO ENSURE THAT THEY WILL MAINTAIN INTEGRITY UNDER NORMAL TO STRENUOUS SHIPPING CONDITIONS, EXCESSIVE HANDLING MAY RESULT IN SOME DAMAGE. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR LOT NUMBER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: EVENT # 1: REPORTS TWO TICE BCG UNITS HAD TUBING PACKAGING THAT HAD A HOLE IN THE PLASTIC, MAKING THE TUBING UNSTERILE.