BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPORVIEW SELF-CONTAINED BIOLOGICAL INDICATOR

    MDR report key: 15259220 · Received August 19, 2022

    Report

    Report Number
    1319130-2022-00004
    Event Type
    Malfunction
    Date Received
    August 19, 2022
    Report Date
    August 19, 2022
    Manufacturer
    SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.
    Product Code
    FRC
    UDI-DI
    10732224721238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CROSSTEX HAS CONTACTED THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, TO DATE WE HAVE NOT RECEIVED ADDITIONAL INFORMATION. THE BI MEDIA IS TRYPITICASE SOY BROTH (TSB) AND IS NON-TOXIC. THE SPORVIEW SELF-CONTAINED BIOLOGICAL INDICATOR INSTRUCTIONS FOR USE STATES, "CAUTION: AFTER PROCESSING THE BI IS HOT AND UNDER PRESSURE. ALWAYS ALLOW TO COOL FOR TEN (10) MINUTES BEFORE CRUSHING. ACTIVATE THE PROCESSED BI WITHIN 8 HOURS AFTER PROCESSING BY GENTLY CRUSHING THE INNER GLASS MEDIA TUBE USING A VIAL CRUSHER." A COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED INHALATION/IRRITATION AND BECAME UNCONSCIOUS AFTER BREAKING A SPORVIEW SELF-CONTAINED BIOLOGICAL INDICATOR. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995289 SPORVIEW SELF-CONTAINED BIOLOGICAL INDICATOR BIOLOGICAL INIDICATOR FRC SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. SCS-106 10732224721238

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown