BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDICATOR DOT TO TAMPER EVIDENT LOCK

    MDR report key: 17655344 · Received August 30, 2023

    Report

    Report Number
    1319130-2023-00010
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Report Date
    August 30, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS PROVIDED BY THE USER FACILITY (2302003). THE LOT HISTORY RECORD WAS REVIEWED, AND NO ABNORMALITIES WERE NOTED. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THE LOT NUMBER SUBJECT OF THE REPORTED EVENT. NO ADDITIONAL INFORMATION WAS OBTAINED FROM THE USER FACILITY IN REGARD TO THE REPORTED PROCEDURE DELAY.

    Additional Manufacturer Narrative · 0

    IT IS LIKELY THAT THE INDICATOR DOTS TURNED WHITE FROM BEING STORED IN DIRECT LIGHTING AS STATED IN THE INSTRUCTIONS FOR USE AND ON THE OUTER PACKAGING LABEL OF THE INDICATOR DOTS. THE AESCULAP STERILCONTAINER SYSTEM INSTRUCTIONS FOR USE STATES, "TAMPER EVIDENT LOCK US910 - LOW TEMPERATURE EXTERNAL CHEMICAL INDICATORS (CIS) ARE PARTICULARLY SENSITIVE AND MUST BE STORED IN A CONTROLLED ROOM TEMPERATURE, AWAY FROM ALKALINE CHEMICALS, ACIDS AND SOURCES OF LIGHT PRIOR TO USE. DO NOT USE BEYOND THE EXPIRATION DATE PROVIDED ON THE OUTSIDE PRODUCT PACKAGING. CHANGE OF COLOR PRIOR TO USE IN THE STERILIZER COULD INDICATE THAT THESE CIS WERE EXPOSED TO TOO MUCH LIGHT OR HIGH TEMPERATURES DURING STORAGE. AFTER BEING PROCESSED, LOW TEMPERATURE TAMPER EVIDENT LOCK SHOULD BE STORED AT A CONTROLLED ROOM TEMPERATURE AWAY FROM ALKALINE CHEMICALS, ACIDS AND SOURCES OF LIGHT. INDICATORS MAY TURN WHITE POST-STERILIZATION IF NOT STORED OUT OF DIRECT LIGHTING." THE OUTER PACKAGING LABEL OF THE INDICATOR DOTS STATES, "CAUTION: STORE AT 20-25°C AVERAGE, EXCURSIONS 15-30°C ALLOWED. RELATIVE HUMIDITY RANGE IS 30-70%. SIGNIFICANT CHANGES IN STORAGE CONDITIONS FOR PROLONGED PERIODS CAN HAVE AN ADVERSE EFFECT ON THE PRODUCT. EXTREME STORAGE CONDITIONS SUCH AS EXPOSURE TO DIRECT SUNLIGHT AND/OR STORAGE ON TOP OF OR NEAR A HEAT SOURCE SHOULD BE AVOIDED. STORE AWAY FROM HYDROGEN PEROXIDE AND OTHER STERILANTS." THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW-UP MDR WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE INDICATOR DOTS ON THEIR TAMPER EVIDENT LOCKS TURNED WHITE AFTER BEING STORED IN THE OPERATING ROOM FOR MULTIPLE WEEKS. A PROCEDURE DELAY WAS REPORTED. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416700 INDICATOR DOT TO TAMPER EVIDENT LOCK INDICATOR DOT TO TAMPER EVICENT LOCK FRG SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. US910 2302003 04046964256967

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown