HEMASHIELD PLATINUM WOVEN STRAIGHT

Additional Manufacturer Narrative

ON DATE OF EVENT, THE EVENT DATE WAS SET ON (B)(6) 2021, AS IS WAS THE DAY THE PRODUCT DAMAGED WAS RECEIVED BY THE CUSTOMER. THE DAMAGE TO THE PRODUCTS OCCURRED BETWEEN THE DAY OF SHIPMENT AND THE DAY OF RECEIPT, WHICH IS BETWEEN (B)(6) 2021. THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 21G28. AS THE DEFECTS APPEAR OBVIOUS ON THE PICTURES PROVIDED, A VISUAL INSPECTION BASED ON PICTURES RECEIVED WAS PERFORMED BY OUR QA SUPERVISOR. HIS CONCLUSION IS AS FOLLOWS : " BASED ON THE PICTURES, I CONFIRM THAT THE PRODUCT IN THE STATE IS NOT IN CONFORMITY. A DAMAGE DURING TRANSPORTATION SEEMS TO BE THE MOST PROBABLE ROOT CAUSE. " THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS AN IMPROPER HANDLING OF THE PACKAGE DURING TRANSPORT. AN INTERNAL NON-CONFORMITY REPORT HAS BEEN INITIATED IN ORDER TO TAKE APPROPRIATE ACTION.

Description of Event or Problem

THE CUSTOMER REFUSED DELIVERY DUE TO DAMAGE: THE PIECE IS BROKEN EVEN THE BOX INSIDE IS DAMAGED BUT THE CONTENTS ARE INTACT. COMPLAINT # (B)(4).