BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RBN-114

    MDR report key: 17594878 · Received August 22, 2023

    Report

    Report Number
    1211566-2023-00010
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 21, 2023
    Manufacturer
    RANFAC CORP
    Product Code
    KNW
    PMA / PMN Number
    K983187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION, IT WAS NOTED THAT THE DEVICE WAS ACTUALLY AN RBN-133. BASED ON THE NOTE PROVIDED BY UPMC, IT IS ASSUMED THAT THE PROVIDER MIXED UP THE DEVICES. THERE WAS NO SAMPLE LOCATED WITHIN THE DEVICE AND WAS BLOCKED BY CORTICAL BONE. THE CORTICAL BONE WAS VISIBLE FROM THE DISTAL END OF THE DEVICE. CORTICAL BONE ENTERED THE LUMEN, BLOCKING THE NEEDLE FROM BEING ABLE TO RETRIEVE THE SPECIMEN. THIS IS TYPICALLY CAUSED BY PREMATURE REMOVAL OF THE STYLET DURING THE PROCEDURE.

    Description of Event or Problem · 0

    1. RANFAC SNARECOIL BONE MARROW BIOPSY NEEDLE WHILE USING BIOPSY SAMPLE STUCK IN NEEDLE UNABLE TO DISLODGE FOR TESTING. HAD TO ATTEMPT FOR ANOTHER SAMPLE USING A DIFFERENT NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301637 RBN-114 SNARECOIL BONE BIOPSY NEEDLE 14 GAUGE KNW RANFAC CORP 74050-01M 49088

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown