BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILCONTAINER FILTER

    MDR report key: 18460808 · Received January 5, 2024

    Report

    Report Number
    1319130-2024-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Report Date
    January 5, 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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED FILTERS FOR EVALUATION. THE PACKAGING WAS NOT INCLUDED WITH THE RETURN AND THE LOT NUMBER IS NOT PRINTED ON THE FILTER, THEREFORE, THE LOT NUMBER COULD NOT BE DETERMINED. THE FILTERS WERE EVALUATED AND NO ISSUES WERE NOTED; THERE WERE NO VISIBLE HOLES ON THE FILTERS. THE REPORTED ISSUE COULD NOT BE CONFIRMED. WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THE PRODUCT CONTINUES TO PERFORM AS EXPECTED.

    Additional Manufacturer Narrative · 0

    THE STERILCONTAINER FILTER SUBJECT OF THE REPORTED EVENT IS BEING RETURNED FOR EVALUATION. INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED INSTRUMENTS SETS WERE REJECTED DUE TO SMALL HOLES IDENTIFIED IN THEIR CONTAINER FILTERS RESULTING IN PROCEDURE DELAYS. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950629 STERILCONTAINER FILTER STERILCONTAINER FILTER KCT SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. US751 04038653473731

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown