BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE IRRIGATION

    MDR report key: 3908321 · Received June 6, 2014

    Report

    Report Number
    1018233-2014-00143
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    May 14, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    KYZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. COMPLAINT IS CONFIRMED WITH UNDETERMINED ROOT CAUSE. THE PICTURE SHOWS ONE PIECE OF GREEN MATERIAL WITH THE SAME COLOR OF THE SYRINGE BULB. THERE IS NO EVIDENCE THAT THIS SMALL PIECE FELL OFF FROM THE BULB AS THE SAMPLE WAS NOT RECEIVED. THIS PRODUCT IS DISTRIBUTED AS BULK PRESENTATION AND THE HOSPITALS STERILIZE THE PRODUCT AND MAKE THEIR KITS. THE MANUFACTURING SITE CANNOT DETERMINE THE EXACT ROOT CAUSE OF THIS ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF THE SYRINGE BROKE OFF DURING USE. PER CONVERSATION WITH COMPLAINANT THE PIECE BROKE OFF AND FELL INTO THE PATIENT AND WAS IN THE JOINT. NO ADDITIONAL MEDICAL INTERVENTION WAS NEEDED AND THE PIECE WAS REMOVED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332256 SYRINGE IRRIGATION KYZ PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1