BN MAR BIOP ASP NDL 8X4 LL X10

Additional Manufacturer Narrative

SUBMIT DATE 01/27/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED. (B)(4)

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A BIOPSY NEEDLE. THE CUSTOMER STATES DURING A BONE BIOPSY PROCEDURE ON ANAL CANCER PATIENT, THE DEVICE HANDLE BROKE OFF. THE EXPOSED PORTION OF THE NEEDLE WAS REMOVED WITH PLIERS. NO ADVERSE PATIENT OUTCOME OCCURRED RELATED TO THIS INCIDENT.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) OF THE LOT NUMBER REPORTED WAS REVIEWED, AND IT WAS CONFIRMED THAT THE PRODUCTS WERE PRODUCED ACCOMPLISHING QUALITY REQUIREMENTS AND WAS RELEASED ACCORDING TO ESTABLISHED PROCEDURES. NO SAMPLE OR PICTURE WAS RECEIVED FOR EVALUATION. DUE TO THIS, THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. THE BONE MARROW ITEM IS NOT MANUFACTURED BY THE PLANT. THIS PRODUCT IS A PICK-AND-PLACE PRODUCT IN THE PLANT PROCESS. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS OPENED TO FOLLOW UP THIS ISSUE AND A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS OPENED AT THE SUPPLIERS TO DETERMINE ROOT CAUSE AND CORRECTIVE ACTIONS. AT THE PLANT, A QUALITY ALERT WAS GENERATED TO NOTIFY INCOMING INSPECTION AND PROCESS PERSONNEL. A POSSIBLE ROOT CAUSE COULD BE RELATED TO LACK OF ADHESIVE BETWEEN THE NEEDLE AND THE HANDLE. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.