BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAP, BOUFFANT, SPUNBONDED, BLUE

    MDR report key: 117750 · Received September 4, 1997

    Report

    Report Number
    1423537-1997-00172
    Event Type
    Malfunction
    Date Received
    September 4, 1997
    Date of Event
    June 11, 1997
    Manufacturer
    ALLEGIANCE HEALTHCARE
    Product Code
    FYF
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING AN MRI THE PHYSICIAN AND STAFF IN MRI WERE BAFFLED AS TO WHY THE IMAGES WERE SHOWING DISTORTED, AS THOUGH A METAL WERE PRESENT. WHEN THE EXAM WAS COMPLETED THE NURSE FOUND A SEWING NEEDLE IN THE BOUFFANT CAP ON THE PT. SHE FOUND IT BY STICKING HERSELF. PT HAD TO UNDERGO ANOTHER MRI AND MORE IMPORTANTLY, HAD THIS NEEDLE COME LOOSE FROM THE CAP DUE TO THE MAGNETIC PULL OF THE SCANNER, IT WOULD HAVE MOVED FREELY ABOUT THE CHAMBER AT A HIGH RATE OF SPEED, POTENTIALLY IMBEDDING HERSELF INTO THE PT, OR WHEN THE NURSE BROUGHT THE PT OUT OF THE SCANNER, THE NEEDLE COULD HAVE BEEN SHOT ACROSS THE ROOM AT A HIGH RATE OF SPEED INJURING ANYONE IN ITS PATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAP, BOUFFANT, SPUNBONDED, BLUE BOUFFANT CAP FYF ALLEGIANCE HEALTHCARE 3274 97CA07611

    Patients

    Seq Age Sex Outcome Treatment
    1