HEMASHIELD PLATINUM WOVEN

Additional Manufacturer Narrative

THE EVENT DATE WAS SET ON (B)(6) 2021, AS IT WAS THE DAY THE PRODUCT DAMAGE WAS DETECTED BY THE CUSTOMER DURING GOODS INSPECTION. HOWEVER, BECAUSE THE SHIPPING CONTAINER WAS INTACT, IT IS ASSUMED THAT THE EVENT HAS OCCURRED BEFORE THIS DATE. ((B)(4)) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 21A27, THE COMPLAINT #: (B)(4) EXCLUDED. ((B)(4)) BASED ON THE PICTURES PROVIDED BY THE CUSTOMER, THE PRODUCT DAMAGE WAS CONFIRMED. IT APPEARS TO BE CAUSED BY A BAD HANDLING OF THE PRODUCT BOX BEFORE SHIPPING. ((B)(4)) THE CONDUCTED INVESTIGATION CONFIRMED THAT THE PRODUCT WAS DEFECTIVE WHEN RECEIVED BY THE CUSTOMER, DUE TO AN HANDLING ISSUE OF THE PRODUCT BOX, WHICH MAY HAVE OCCURRED BEFORE SHIPPING. THEREFORE, AN INTERNAL NON-CONFORMITY REPORT HAS BEEN INITIATED IN ORDER TO INVESTIGATE THE ROOT CAUSE AND TO TAKE APPROPRIATE CORRECTIVE ACTIONS IF NECESSARY.

Description of Event or Problem

AT GOODS RECEIPT, DURING INCOMING INSPECTION PERFORMED BY THE CUSTOMER (DISTRIBUTOR), THREE PRODUCTS (B)(4) WERE REFUSED DUE TO A DAMAGE ON THE PRODUCT BOX. HOWEVER, THE SHIPPING CARTON WAS INTACT. COMPLAINT # (B)(4). THIS MDR IS PART OF A SERIES OF THREE MDRS INVOLVING THE THREE NONCONFORMING PRODUCTS. (SERIAL NUMBERS (B)(4)).