BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND FILTERS WITH INDICATOR

    MDR report key: 18791195 · Received February 27, 2024

    Report

    Report Number
    1319130-2024-00003
    Event Type
    Malfunction
    Date Received
    February 27, 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
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED SAMPLES FROM THE SUBJECT LOT BACK FOR EVALUATION. DURING EVALUATION AND TESTING OF THE RETURNED ROUND FILTERS WITH INDICATOR, THE REPORTED EVENT WAS UNABLE TO BE DUPLICATED. NO ISSUES WERE NOTED, AND THE INDICATOR DOT TURNED DARK BROWN AS STATED ON THE ROUND FILTER. THE INSTRUCTION FOR USE FOR THE AESCULAP STERIL CONTAINER 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." RETAIN TESTING WAS CONDUCTED ON THE LOT SUBJECT OF THE REPORTED EVENT AND NO ISSUES WERE NOTED. THE REPORTED EVENT WAS UNABLE TO BE DUPLICATED. A COMPLAINT REVIEW WAS COMPLETED AND CONFIRMED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE INDICATOR DOT ON THEIR ROUND FILTERS WITH INDICATOR ARE NOT "UNIFORMLY DARK BROWN" AFTER PROCESSING. PROCEDURE CANCELLATIONS WERE REPORTED AS THE DEVICES WERE NOT UTILIZED AND WERE REPROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628381 ROUND FILTERS WITH INDICATOR INDICATOR KCT SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. US751 2310002 04038653473731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown