BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RBN-114

    MDR report key: 4977053 · Received August 6, 2015

    Report

    Report Number
    1211566-2015-00008
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 17, 2015
    Report Date
    August 6, 2015
    Manufacturer
    RANFAC CORP.
    Product Code
    KNW
    PMA / PMN Number
    K983187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEEDLE #1 HAD A BONE FRAGMENT STUCK IN THE SNARE WHICH DID NOT ALLOW THE SNARE TO OPEN OR CLOSE. ONCE WE REMOVED THE FRAGMENT, THE SNARE RELEASED; HOWEVER, THE FRAGMENT BROKE THE SNARE. THE BONE FRAGMENT DID NOT ALLOW THE SAMPLE TO ENTER INTO THE NEEDLE. NEEDLE #2 HAD SOME SORT OF PAPER-LIKE SUBSTANCE BALLED-UP INSIDE THE NEEDLE WHICH DID NOT ALLOW A SAMPLE TO ENTER THE NEEDLE. ONCE THE SUBSTANCE WAS REMOVED, THE SNARE FUNCTIONED ACCORDINGLY. NEEDLE #3 FUNCTIONED ACCORDINGLY AFTER IT WAS REMOVED FROM THE DECON (CIDEX). WE FOUND NO PROBLEMS WITH THIS NEEDLE.

    Description of Event or Problem · 1

    PER CLASSIC MEDICAL EMAILED COMPLAINT: OVER THE LAST FEW WEEKS THERE HAVE BEEN SEVERAL NEEDLES THAT HAVE MALFUNCTIONED WHEN TRYING TO REMOVE A CORE SAMPLE. THIS HAS RESULTED IN HAVING TO GET A NEW NEEDLE AND HAVING TO PERFORM ANOTHER BIOPSY ON PATIENTS. THE WAY IT IS BEING DESCRIBED TO ME IS THAT THE PIECE THAT IS USED TO PUSH THE CORE SAMPLE OUT IS NO FITTING PROPERLY AND IT IS AS THOUGH THE NEEDLE IS STILL IN THE CLOSED POSITION, ALTHOUGH THE NEEDLE IS OPEN. 2 OF THE NEEDLES WERE FROM THE SAME LOT, BUT JUST YESTERDAY ONE CAME UP FROM A SEPARATE LOT #. THE 2 LOT NUMBERS ARE 32544 AND 32683.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520330 RBN-114 BONE BIOPSY NEEDLE 11 GAUGE KNW RANFAC CORP. 74076-01M 32683

    Patients

    Seq Age Sex Outcome Treatment
    1