BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILCONTAINER FILTER

    MDR report key: 18160989 · Received November 17, 2023

    Report

    Report Number
    1319130-2023-00012
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Report Date
    November 17, 2023
    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 INVESTIGATION OF THE REPORTED EVENT IS IN PROCESS; A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE LOT NUMBERS SUBJECT OF THE REPORTED EVENT ARE 2308007, 2308001, 2307004, 2304001, 2301003, 2301006, AND 2211003.

    Additional Manufacturer Narrative · 0

    CROSSTEX HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE REPORTED EVENT. TO DATE, WE HAVE NOT RECEIVED A RESPONSE. AS NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT, A ROOT CAUSE COULD NOT BE DETERMINED. CROSSTEX WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TINY HOLES WERE IDENTIFIED IN THEIR CONTAINER FILTERS CAUSING PROCEDURE DELAYS. THE USER FACILITY CONFIRMED THE INSTRUMENTS WERE RE-STERILIZED PRIOR TO USE. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745279 STERILCONTAINER FILTER STERILCONTAINER FILTER KCT SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. US751 04038653473731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown