BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND FILTER POLYPROVPYLENE

    MDR report key: 3196807 · Received June 25, 2013

    Report

    Report Number
    2916714-2013-00036
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    March 29, 2013
    Report Date
    May 7, 2013
    Manufacturer
    SPS MEDICAL SUPPLY CORP
    Product Code
    FRG
    PMA / PMN Number
    K040865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510 (K): K093493, K093649 AND K112671. EVALUATION: THE RETURNED FILTER FROM THE TOP OF THE CONTAINER SHOWED THAT IT WAS QUITE DISTORTED AND HAD SEEN A TEMPERATURE HIGHER THAN THE 270 DEGREES FAHRENHEIT THAT THE STERILIZER WAS SET AT. WITH THE FACT THAT IT WAS THE TOP FILTERS AND NO OTHERS; THE MOST PROBABLE CAUSE WAS STERILIZER OVERLOAD. THE TOP OF THIS CONTAINER WITH THIS FILTER WAS VERY CLOSE OR TOUCHING THE TOP OF THE CHAMBER WHERE THE TEMPERATURE IS MUCH HOTTER. DETERMINED TO BE USER RELATED AND NOT PRODUCT RELATED.

    Description of Event or Problem · 1

    TOP FILTER WAS APPEARING TO BE MELTED WHEN THE SET WAS OPENED IN THE OPERATING ROOM. BOTTOM FILTER APPEARED FINE AND NO OTHER SETS HAVE HAD THIS MELTING PROBLEM. NO PT INJURY. SURGERY WAS DELAYED 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289154 ROUND FILTER POLYPROVPYLENE FRG SPS MEDICAL SUPPLY CORP MD344 1302

    Patients

    Seq Age Sex Outcome Treatment
    1 Other