BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMBIBE BONE MARROW ASPIRATION NEEDLE

    MDR report key: 2585541 · Received May 18, 2012

    Report

    Report Number
    2530131-2012-00008
    Event Type
    Injury
    Date Received
    May 18, 2012
    Date of Event
    May 9, 2012
    Report Date
    May 9, 2012
    Manufacturer
    ORTHOVITA, INC.
    Product Code
    KNW
    PMA / PMN Number
    K050795
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RESERVE SAMPLE OF THE DEVICE IN QUESTION WAS TESTED FOR ITS ABILITY TO DRAW, HOLD, AND EXPEL WATER FROM A RESERVOIR. IT WAS SHOWN THAT WHEN ATTACHED TO A 30 CC SYRINGE (PN (B)(4), LOT A1105020 - AS USED IN THIS CASE) THE DEVICE WAS ABLE TO PERFORM THESE FUNCTIONS AS INTENDED. FURTHERMORE, BATCH RECORD REVIEW SHOWED THAT THE NEEDLES AND SYRINGES MET ALL RELEASE SPECIFICATIONS. A POTENTIAL FAILURE MODE IS THAT THE FENESTRATIONS CAUSED A LEAK IN THE VACUUM SYSTEM NECESSARY FOR A NEEDLE/SYRINGE SYSTEM TO ASPIRATE BONE MARROW. AS THERE IS LITTLE BONE MARROW IN THE CALCANEUS, NOT ALL FENESTRATIONS MAY HAVE BEEN SUBMERGED IN THE FLUID. SHOULD ANY FURTHER INFO BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE (NEEDLE AND SYRINGE) WERE USED IN CALCANEAL BONE MARROW ASPIRATION. THE SURGEON COULD NOT GAIN APPROPRIATE SUCTION TO DRAW BONE MARROW AND RE-PLACED THE NEEDLE. THE SURGEON WAS STILL NOT ABLE TO GAIN APPROPRIATE SUCTION WITH THE REPOSITIONED DEVICE. THERE WAS A THREE MINUTES SURGICAL DELAY (APPROXIMATELY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMBIBE BONE MARROW ASPIRATION NEEDLE INSTRUMENT, BIOPSY KNW ORTHOVITA, INC. T1110005

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other