BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE MARROW ASPIRATION (BMA) NEEDLE

    MDR report key: 2033489 · Received March 23, 2011

    Report

    Report Number
    1211566-2011-00002
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 9, 2011
    Report Date
    March 18, 2011
    Manufacturer
    RANFAC CORP.
    Product Code
    LWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RANFAC CORP, THE MFR, HAS SPOKEN WITH THE DOCTOR. THE DEVICE IS A BONE MARROW ASPIRATION NEEDLE. THE INSTRUCTIONS FOR USE CLEARLY STATE "USING GENTLE (BUT FIRM) PRESSURE, ADVANCE THE NEEDLE BY ROTATING IN AN ALTERNATING CLOCKWISE-COUNTERCLOCKWISE MOTION. ENTRANCE INTO THE MARROW CAVITY IS GENERALLY DETECTED BY DECREASED RESISTANCE." THE DOCTOR USED A MALLET TO DRIVE THE NEEDLE INTO THE MARROW CAVITY. WHEN IT WAS TIME TO WITHDRAW THE NEEDLE THE FORCE REQUIRED WAS GREATER THAN THAT OF THE STAINLESS STEEL. THE RESULT WAS THE HANDLE BEING BROKEN OFF OF THE CANNULA. AT THAT POINT, INTERVENTION BECAME NECESSARY. THE SAME SCENARIO WAS REPEATED ON THE OTHER SIDE OF THE PT. THE NEEDLE WAS NOT USED IN ACCORDANCE WITH THE INSTRUCTIONS RESULTING IN THIS PRODUCT PROBLEM. THE "SHALLOW" THIRD PENETRATION WAS SUCCESSFUL BECAUSE THE NEEDLE WAS NOT ADVANCED AS FAR. ADD'L LOT# 20534-2.

    Description of Event or Problem · 1

    DR. (B)(6) REPORTED HE WAS ATTEMPTING TO ASPIRATE BONE MARROW FROM A (B)(6). AFTER ROUTINE DEEP INSERTION OF THE BONE MARROW ASPIRATION NEEDLE INTO THE ANTERIOR PELVIS (VERY HARD BONE WAS NOTICED) AND SUBSEQUENT ASPIRATION OF ABOUT 5 ML MARROW, DR. (B)(6) ATTEMPTED TO ROTATE THE TROCAR 90 DEGREES (PER STANDARD PROTOCOL). AFTER PENETRATING THE CORTEX OF THE PELVIS, DOCTOR ENCOUNTERED VERY HARD BONE. THE NEEDLE DID NOT WANT TO ROTATE, SO WHEN HE EXERTED ADD'L TORQUE TO ROTATE THE NEEDLE, THE METAL CANNULA NEAR THE HANDLE FAILED (BROKE) RESULTING IN THE HANDLE BEING INDEPENDENT OF THE CANNULA WHICH REMAINED IN BONE. HE THEN ATTACHED A POWER DRILL AND CHUCK TO THE METAL CANNULA AND "POWERED" THE CANNULA OUT OF THE BONE. HE THEN ATTEMPTED TO HARVEST BONE MARROW ASPIRATE FROM THE OPPOSITE PELVIS WITH THE SAME RESULT AND CORRECTION. HE THEN DECIDED TO MAKE A THIRD, BUT "SHALLOW" PENETRATION INTO THE PELVIS THAT SUCCESSFULLY RESULTED IN 120 ML MARROW BEING ASPIRATED AND THE REST OF THE SURGICAL PROCEDURES WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE MARROW ASPIRATION (BMA) NEEDLE BONE MARROW ASPIRATION (BMA) KIT LWE RANFAC CORP. RAN-11-1 20533-2

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention NO REPORT.