BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE MARROW BIOPSY NEEDLE, RBN-84 PN

    MDR report key: 13151407 · Received January 4, 2022

    Report

    Report Number
    13151407
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    December 6, 2021
    Report Date
    December 7, 2021
    Manufacturer
    RANFAC CORP.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT PRESENTED TO (B)(6) CLINIC FOR BONE MARROW BIOPSY. PROCEDURE PROGRESSED SMOOTHLY. INSERTED JAMSHIDI NEEDLE INTO BONE AND CORED SAMPLE OF MARROW. UPON TRYING TO REMOVE THE JAMSHIDI NEEDLE, THE BLUE PLASTIC HANDLE BROKE AND SEPARATED FROM THE OUTER CORE NEEDLE. WHILE STERILE, I ATTEMPTED TO REMOVE THE NEEDLE BUT COULD NOT AT THIS TIME. PATIENT WAS INFORMED TO WHAT HAPPENED AND REMAINED CALM. PAGED ORTHO CONSULT SERVICE WHO SUGGESTED USING HEMOSTAT FOR REMOVAL WITH NEEDLE CORE IN PLACE TO PREVENT CRUSHING OF OUTER CORE. I DONNED STERILE GLOVES AND WAS HANDED CLEAN HEMOSTATS BY PATH TECH. APPLIED HEMOSTATS TO JAMSHIDI NEEDLE AND PULLED IN LINE WHILE ROTATING NEEDLE. NEEDLE CAME OUT OF BONE AND CORE MARROW SAMPLE WAS PRESERVED. PATIENT WAS CLEANED AGAIN WITH CHLORAPREP AND DRESSING WAS APPLIED TO BIOPSY SITE. PATIENT WAS GIVEN INSTRUCTIONS ON SIGNS AND SYMPTOMS OF INFECTION AND HOW TO REPORT TO PROVIDER. TOTAL TIME OF NEEDLE IN PELVIS WAS APPROXIMATELY 30 MINUTES, NO PROPHYLACTIC ANTIBIOTICS GIVEN. PATIENT THEN PROCEEDED TO RADIOLOGY FOR DXR: PELVIS TO ENSURE NO FOREIGN BODY LEFT IN PELVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160018 BONE MARROW BIOPSY NEEDLE, RBN-84 PN INSTRUMENT, BIOPSY KNW RANFAC CORP. 8 GAUGE X 4 48402

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown