BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RBN-114

    MDR report key: 4168560 · Received October 14, 2014

    Report

    Report Number
    1211566-2014-00013
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    August 29, 2014
    Report Date
    October 10, 2014
    Manufacturer
    RANFAC CORP.
    Product Code
    KNW
    PMA / PMN Number
    K983187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, DEVICES WERE CONTAMINATED. PROBE WAS INSERTED, AND WE FOUND IT DIFFICULT TO PUSH OUT THE SPECIMEN. WITH EXTRA FORCE, WE REMOVED THE SPECIMEN, HOWEVER, THERE WAS MINIMAL SPECIMEN PRESENT. BONE FRAGMENTS WERE FOUND INSIDE EACH OF THE SNARES CAUSING THE SNARE NOT TO BE ABLE TO MOVE FREELY, AND DID NOT ALLOW THE SPECIMEN TO ENTER INTO THE CANNULA. REMOVING THE STYLET TOO EARLY IS THE MOST LIKELY CAUSE OF BONE FRAGMENTS ENTERING THE CANNULA AND JAMMING THE SNARE. WE WILL COMMUNICATE THESE FINDINGS WITH THE CUSTOMER VIA THIS CORRECTIVE ACTION.

    Description of Event or Problem · 1

    PER (B)(6), "CANNOT RETRIEVE SPECIMEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650714 RBN-114 BONE BIOPSY NEEDLE 11 GAUGE KNW RANFAC CORP. 74092-01M 29085B19

    Patients

    Seq Age Sex Outcome Treatment
    1