RECONSTITUTION ACCESSORIES

Additional Manufacturer Narrative

(B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A THOROUGH SAMPLE ANALYSIS OR BATCH RECORD REVIEW COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. 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 (B)(4) STANDARDS DURING DEVELOPMENT TO ENSURE THAT THEY WILL MAINTAIN INTEGRITY UNDER NORMAL TO STRENUOUS SHIPPING CONDITIONS, EXCESSIVE HANDLING MAY RESULT IN SOME DAMAGE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG 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 RECONSTITUTION ACCESSORIES WERE DAMAGED WITH HOLES IN THE PLASTIC WHERE THE LABELS ARE PLACED.