HEMASHIELD PLATINUM WOVEN STRAIGHT

Additional Manufacturer Narrative

THE EVENT DATE WAS SET ON (B)(6) 2021, AS IS WAS THE DAY THE PRODUCT DAMAGED WAS DETECTED 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 AND (B)(6) 2021. (4109/212) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 21F16. (4112/3236) AS THE DEFECTS APPEAR OBVIOUS ON THE PICTURES PROVIDED, A VISUAL INSPECTION BASED ON PICTURES RECEIVED WAS PERFORMED BY OUR QA SUPERVISOR. HER CONCLUSION ARE AS FOLLOWS: "I CONFIRM THAT THE TWO PRODUCTS IN THE STATE ARE NOT IN CONFORMITY. A DAMAGE DURING TRANSPORTATION SEEMS TO BE THE MOST PROBABLE ROOT CAUSE." (4308) 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

THIS MDR IS PART OF A SERIES OF 2 COMPLAINTS INVOLVING 2 PRODUCTS DELIVERED IN SAME PARCEL AND RELATED TO A SINGLE EVENT. BOTH PRODUCTS WERE DELIVERED DAMAGED, AS THE INNER PACKING WAS CRUSHED. COMPLAINT : #(B)(4).