BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND FILTERS WITH INDICATOR

    MDR report key: 18791167 · Received February 27, 2024

    Report

    Report Number
    1319130-2024-00002
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    January 29, 2024
    Report Date
    February 27, 2024
    Manufacturer
    SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.
    Product Code
    KCT
    UDI-DI
    04038653473731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY SENT BACK SAMPLES OF THE ROUND FILTERS WITH INDICATOR FOR EVALUATION. THE ROUND FILTERS WITH INDICATOR WERE PROCESSED, AND ALL SAMPLES EVIDENCED PASSING RESULTS; THE INDICATOR DOT CHANGED FULLY IN COLOR. THE REPORTED EVENT WAS UNABLE TO BE DUPLICATED. THE INSTRUCTION FOR USE FOR THE AESCULAP STERILCONTAINER SYSTEM INSTRUCTIONS FOR USE STATES (PG.25), "AFTER STERILIZATION, THE EXTERNAL INDICATOR SHOULD CHANGE FROM THE ORIGINAL INDICATOR COLOR TO INDICATE EXPOSURE TO STERILANT. THE POST STERILIZATION INDICATOR COLOR MAY VARY AND NOT BE EVENLY SHADED. EXTREME STORAGE CONDITIONS SUCH AS EXPOSURE TO DIRECT SUNLIGHT AND/OR STORAGE ON TOP OF OR NEAR HEAT SOURCE SHOULD BE AVOIDED. DO NOT USE IF THE INDICATOR DOT COLOR HAS CHANGED BEFORE BEING PROCESSED. INDICATORS MAY TURN WHITE POST-STERILIZATION IF NOT STORED OUT OF DIRECT LIGHTING." AS NO ISSUES WERE NOTED WITH THE SAMPLES PROVIDED BY THE CUSTOMER AND THE REPORTED EVENT COULD NOT BE DUPLICATED, A ROOT CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE FILTER INDICATOR DOT DID NOT FULLY CHANGE IN COLOR. A PROCEDURE DELAY WAS REPORTED AS THE DEVICES WERE NOT UTILIZED AND WERE REPROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656159 ROUND FILTERS WITH INDICATOR INDICATOR KCT SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. US751 04038653473731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown