BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BN MAR BIOP ASP NDL 8X4 LL X10

    MDR report key: 5392605 · Received January 27, 2016

    Report

    Report Number
    1282497-2016-00012
    Event Type
    Malfunction
    Date Received
    January 27, 2016
    Date of Event
    November 20, 2015
    Report Date
    January 4, 2016
    Manufacturer
    COVIDIEN
    Product Code
    OIJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52803 BN MAR BIOP ASP NDL 8X4 LL X10 BIOPSY NEEDLE OIJ COVIDIEN 8881247087 143530348X

    Patients

    Seq Age Sex Outcome Treatment
    1