BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUB-X CLEARING AGENT

    MDR report key: 7567358 · Received June 4, 2018

    Report

    Report Number
    1419341-2018-00002
    Event Type
    Injury
    Date Received
    June 4, 2018
    Date of Event
    May 4, 2018
    Report Date
    October 30, 2018
    Manufacturer
    LEICA BIOSYSTEMS RICHMOND
    Product Code
    KEM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLIER CORRECTIVE ACTION RECORD (SCAR) 35 WAS ISSUED TO THE SUPPLIER OF SUB-X CLEARING AGENT. THE SUPPLIER CONDUCTED AN INVESTIGATION WHICH WAS COMPLETED AND APPROVED ON 24JUL2018. THE PRODUCT WAS DISPOSED OF BY THE CUSTOMER THEREFORE, A LEICA BIOSYSTEM (LBS) RICHMOND RETAIN SAMPLE WAS SENT TO THE SUPPLIER. THE RETAIN WAS FOUND TO CONTAIN APPROXIMATELY 0.12% OF A FOREIGN ALIPHATIC PRODUCT. NO ODOR WAS DETECTED IN THE SUPPLIER'S RETAIN SAMPLE. INVESTIGATION OF LBS RICHMOND'S RETAIN PROCESS WAS COMPLETED BY A CROSS FUNCTIONAL LBS RICHMOND TEAM. THE INVESTIGATION IDENTIFIED THAT THE ROOT CAUSE OF THE ODOR WAS A CONTAMINATION ORIGINATING FROM THE 55-GALLON DRUM SENT FROM THE SUPPLIER. CORRECTIVE ACTION/ PREVENTATIVE ACTIONS (CAPAS) WERE IDENTIFIED AND IMPLEMENTED WITH THE SUPPLIER REGARDING PROPER DRUM INSPECTIONS PRIOR TO FILLING PRODUCT AND PROPER HOSE CLEANING PROCEDURES ON (B)(6) 2018. NO NEW COMPLAINTS FOR THIS ISSUE HAVE BEEN REPORTED FROM (B)(6) 2018 THROUGH (B)(6) 2018. LBS RICHMOND WILL CONTINUE TO TRACK AND TREND. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PRODUCT RETAINS CURRENTLY BEING EVALUATED BY MANUFACTURER. AN INVESTIGATION IS CURRENTLY UNDERWAY AND A FOLLOW-UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2018, FOUR CUSTOMER EMPLOYEES WERE EXPOSED TO CHEMICAL FUMES WHILE THE PRODUCT WAS IN USE IN THE CUSTOMER'S MOBILE UNIT. ONE OF THE FOUR CUSTOMER EMPLOYEES SOUGHT MEDICAL ATTENTION FOR A MIGRAINE. SYMPTOMS WERE REPORTED TO HAVE SUBSIDED BY (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409034 SUB-X CLEARING AGENT SUB-X CLEARING AGENT KEM LEICA BIOSYSTEMS RICHMOND 3803672 030718

    Patients

    Seq Age Sex Outcome Treatment
    1 Other