BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSN-132, F/G, STERILE, COVIDIEN

    MDR report key: 3940535 · Received April 18, 2014

    Report

    Report Number
    1211566-2014-00004
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    November 1, 2013
    Report Date
    March 26, 2014
    Manufacturer
    RANFAC CORP.
    Product Code
    KNW
    PMA / PMN Number
    K983187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT REC'D BY RANFAC CORP. FOR ANALYSIS. DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO ISSUES WERE IDENTIFIED. DHR REVIEW WAS SENT TO (B)(4) FOR THEIR REVIEW.

    Description of Event or Problem · 1

    PER THE MAUDE EVENT REPORT, THE BONE MARROW NEEDLE WAS PLACED APPROPRIATELY. UNABLE TO ESTABLISH NECESSARY SUCTION WITH SYRINGE TO OBTAIN ASPIRATE SPECIMEN. THE BIOPSY WAS SUCCESSFULLY OBTAINED. ALTHOUGH A CORE SPECIMEN WAS OBTAINED, THE BIOPSY NEEDLE COULD NOT BE USED TO OBTAIN AND ASPIRATE SPECIMEN OF THE PATIENTS BONE MARROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238728 GSN-132, F/G, STERILE, COVIDIEN GSN-132 KNW RANFAC CORP. 74026-05M 26759X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK