BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND FILTERS W/INDICATOR

    MDR report key: 3823549 · Received February 28, 2014

    Report

    Report Number
    2916714-2014-00089
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    January 13, 2013
    Report Date
    February 17, 2014
    Manufacturer
    SPS MEDICAL
    Product Code
    FRG
    PMA / PMN Number
    K062510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: K062510; K792558. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    PIN HOLE IN US751 FILTER WAS NOTICED AFTER THE INSTRUMENTS WERE PRESENTED TO THE STERILE FIELD. THE FIELD WAS THEN CONSIDERED CONTAMINATED AND THE INSTRUMENTS AND SUPPLIES HAD TO BE RE-DONE. PATIENT WAS NOT IN THE ROOM. NO PATIENT INJURY; SURGERY PROLONGED 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123835 ROUND FILTERS W/INDICATOR FRG SPS MEDICAL US751 1307/1306

    Patients

    Seq Age Sex Outcome Treatment
    1 Other