BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DE BAKEY SLIM NEEDLEHOLDER 23 CM TOP DUR

    MDR report key: 10168052 · Received June 18, 2020

    Report

    Report Number
    9612278-2020-00001
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 14, 2020
    Report Date
    June 18, 2020
    Manufacturer
    DUFNER INSTRUMENTE GMBH
    Product Code
    FHQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BY MEANS OF FUNCTIONAL TESTING ON THE RETURNED PRODUCT AND PRODUCT IN STOCK, THE CAUSE WAS TRACED TO A NONCONFORMANCE IN MANUFACTURING AFFECTING LOT #8170368 IN ADDITION TO LOT #8180673 CITED ABOVE. A RECALL HAS BEEN INITIATED. THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IN PREPARATION FOR USE DURING SURGERY, THE NEEDLE HOLDER WAS USED TO GRASP A SUTURING NEEDLE. THE TIP INSERT BROKE OUTSIDE THE PATIENT, BEFORE THE NEEDLE HOLDER COULD BE HANDED OVER TO THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635900 DE BAKEY SLIM NEEDLEHOLDER 23 CM TOP DUR NEEDLEHOLDER FHQ DUFNER INSTRUMENTE GMBH 08180673

    Patients

    Seq Age Sex Outcome Treatment
    1