BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPSY NEEDLE KIT

    MDR report key: 972180 · Received December 21, 2007

    Report

    Report Number
    1723170-2007-00011
    Event Type
    Other
    Date Received
    December 21, 2007
    Date of Event
    November 29, 2007
    Report Date
    December 21, 2007
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    KNW
    PMA / PMN Number
    K971247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPEATED ATTEMPTS AT OBTAINING PT WEIGHT UNSUCCESSFUL. LAWS GOVERNING SHIPMENT OF MATERIALS CONSIDERED TO BE BIOHAZARDOUS PREVENT RETURN OF USED DEVICE TO MFR. IDENTIFIED AND MEDIATED MFG STEPS THAT HAD ALLOWED SMALL PLASTIC FILINGS TO REMAIN WITHIN CANNULA HUB ASSEMBLY. VENDOR MFG PROCESS CHANGED TO ELIMINATE POSSIBILITY OF FILINGS REMAINING IN ASSEMBLY.

    Description of Event or Problem · 1

    IN 2007, SITE DID A PASSIVE BIOPSY AND FOUND A PIECE OF BLUE PLASTIC IN THEIR SAMPLE. THEY FILLED THE NEEDLE WITH SALINE BEFORE DOING THE BIOPSY THEN THEY GUIDED THE NEEDLE INTO THE PT AND ASPIRATED A SPECIMEN. WHEN THEY FLUSHED THE SPECIMEN THEY FOUND A PIECE OF BLUE PLASTIC IN IT. THE BIOPSY NEEDLE LOT NUMBER IS 066125407. DR. PERFORMED CT SCAN IN THE SAME DAY TO CONFIRM PT OUTCOME FROM PROCEDURE WAS NOT NEGATIVELY AFFECTED. PT INFO RECEIVED BUT NO PT WEIGHT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSY NEEDLE KIT BIOPSY NEEDLE KIT, 9733068, PASSIVE KNW MEDTRONIC NAVIGATION, INC. 9733068 066125407

    Patients

    Seq Age Sex Outcome Treatment
    1 YR