BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM REUSABLE CORE INSTRUMENT

    MDR report key: 3810095 · Received April 10, 2014

    Report

    Report Number
    2020394-2014-00164
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Report Date
    March 12, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K934371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW WAS CONDUCTED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE LOT MET ALL RELEASE CRITERIA. PER THE SERVICE AND REPAIR FACILITY, IT WAS FOUND THAT THE INSTRUMENT FIRED WITHOUT PRESSING THE TRIGGER. UPON FURTHER EXAMINATION OF THE DEVICE, IT WAS NOTED THAT THE DRIVE PIN ON THE CANNULA SLED WAS NOT PROPERLY INSTALLED IN THE SLED, IT WAS INSTALLED ROTATED 180 DEGREES. THE ROOT CAUSE IS MANUFACTURING/SUPPLER RELATED. THE REPORTED EVENT OCCURRED AS A RESULT OF THE REVERSED CANNULA SLED PIT THAT HAVE PREVENTED THE INSTRUMENT FROM ENERGIZING PROPERLY. THE INVESTIGATION IS CONFIRMED FOR SELF-ACTIVATION, AS THE INSTRUMENT FIRED WITHOUT PRESSING THE TRIGGER DUE TO AN IMPROPERLY INSTALLED DRIVE PIN.

    Additional Manufacturer Narrative · 1

    TO ENSURE COMPLIANCE TO 21 CFR 803.50 A RETROSPECTIVE REVIEW OF THIS FILE WAS CONDUCTED TO DETERMINE IF GOOD FAITH EFFORTS WERE MADE TO OBTAIN THE REQUIRED INFORMATION AND/OR AN EXPLANATION OF WHY ANY REQUIRED INFORMATION WAS NOT PROVIDED. A FOLLOW UP WAS MADE WITH THE INTERNATIONAL REPRESENTATIVE TO OBTAIN ANY INFORMATION PERTAINING TO THE PATIENT, PRODUCT, AND/OR PROCEDURAL DETAILS (E.G. DATE OF THE EVENT, RELEVANT TEST DATA, RELEVANT HISTORY, LOT #, CATALOG #, IMPLANT AND/OR EXPLANTED DATES, AND CONCOMITANT PRODUCT(S) OR THERAPY) THAT WERE NOT PREVIOUSLY OBTAINED DURING THE INITIAL INVESTIGATION. THE INTERNATIONAL REPRESENTATIVE DID NOT HAVE ANY ADDITIONAL DETAILS TO PROVIDE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SOMETIMES FIRES WITHOUT THE FIRE BUTTON BEING PUSHED. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216334 MAGNUM REUSABLE CORE INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1