BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE MARROW NEEDLE (J TYPE)

    MDR report key: 2496241 · Received March 14, 2012

    Report

    Report Number
    1417485-2012-00001
    Event Type
    Injury
    Date Received
    March 14, 2012
    Date of Event
    February 23, 2012
    Report Date
    February 27, 2012
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC., DBA ANGIOTECH
    Product Code
    DWO
    PMA / PMN Number
    K890925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BONE NEEDLE WAS USED IN A (B)(6) PT. THREE RETAINED SAMPLES FROM THE LOT INVOLVED IN THE EVENT WERE EVALUATED AND MET SPECS. THE REPORTER STATED THE DEVICE PERFORMED AS INTENDED AND THE EVENT OCCURRED DURING DEVICE REMOVAL. THE DEVICE IN QUESTION WAS NOT RETURNED FOR EVAL. THE PROCEDURE WAS PERFORMED IN THE ILIUM. THE REPORTER STATED THE DOCTOR DID NOT ROTATE THE DEVICE RIGHT AND LEFT; INSTEAD, THE DOCTOR PULLED WITH STRENGTH WHEN RESISTANCE WAS FELT AND THE NEEDLE COULD NOT BE REMOVED EASILY. THE CANNULA IS DESIGNED TO BE ROTATED BACK AND FORTH AND WORKS OPTIMALLY WHEN USING THIS MOTION RATHER THAN PULLING OR WAVING THE NEEDLE. THE REPORTER ALSO STATED THE PHYSICIAN USED A 13G NEEDLE WHEN AN 11G WOULD HAVE BEEN OPTIMAL.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM OUR OEM CUSTOMER IN (B)(6): A FOURTH YEAR RESIDENT USED A 13G X 10CM BONE MARROW BIOPSY NEEDLE FOR BONE MARROW ACQUISITION IN THE PT'S PELVIS. WHEN TRYING TO REMOVE THE NEEDLE, THE PHYSICIAN FELT THE NEEDLE STICK AND DIFFICULT TO REMOVE BECAUSE THE PT'S BONE WAS TOO HARD FOR 13G NEEDLE. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN PULLED AND WAVED THE NEEDLE A BIT, WHICH ULTIMATELY CAUSED A SEVERANCE OF THE NEEDLE. THE RESIDENT PHYSICIAN HAD TO MAKE AN INCISION TO REMOVE THE CUT-OFF NEEDLE FROM THE PT. THE SEVERED PIECE OF NEEDLE WAS REMOVED WITHOUT ANY FURTHER PROBLEM. THE PT FEELS FINE EXCEPT FOR REMOVAL INCISION. INCIDENT OCCURRED AT (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE MARROW NEEDLE (J TYPE) BONE MARROW BIOPSY NEEDLE DWO MANAN MEDICAL PRODUCTS, INC., DBA ANGIOTECH IMKBMN-13R-10 EH62

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention