BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILCONTAINER S STER LOCKS PINK

    MDR report key: 18263685 · Received December 4, 2023

    Report

    Report Number
    1319130-2023-00015
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 6, 2023
    Report Date
    December 4, 2023
    Manufacturer
    SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.
    Product Code
    FRG
    UDI-DI
    04046964256967
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE STERILE CONTAINER LOCK 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 THAT THE PINK INDICATOR DOT ON THE STERILE CONTAINER LOCK TURNED WHITE INSTEAD OF BLUE AFTER PROCESSING. A PROCEDURE DELAY WAS REPORTED. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048758 STERILCONTAINER S STER LOCKS PINK STERILCONTAINER LOCK FRG SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. US910 2212003 04046964256967

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown