BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAEMOLANCE LANCET

    MDR report key: 2359710 · Received October 3, 2011

    Report

    Report Number
    9613304-2011-00004
    Event Type
    Injury
    Date Received
    October 3, 2011
    Date of Event
    February 15, 2010
    Report Date
    September 30, 2011
    Manufacturer
    HTL-STREFA S.A.
    Product Code
    FMK
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HTL REGISTERED A COMPLAINT AS 410/ARKRAY HAEMOLANCE LOW 150/142/2011/RJL. IT IS HIGHLY PROBABLE THAT THE PRODUCTION OF PRODUCT TYPE 410, MFG IN THE YEAR 2008 HAVE THE DEFECT OF PROBLEMS WITH THE BUTTON MATERIAL DURING THE SAFETY TAB TWIST OF MOMENT OR DURING ACTIVATION CAUSING ITS CRACKING. IT WAS INVESTIGATED THAT CRACKING PUSH-BUTTONS CAN POTENTIALLY LEAD TO NEEDLE RETRACTION ISSUES. FROM THE MOMENT OF THE FIRST CLAIM CONNECTED WITH LOW QUALITY OF COMPONENT MATERIAL AND COMPONENT CRACKING DURING USAGE THE RESPECTIVE ACTIONS TO ELIMINATE THE DEFECT HAVE BEEN UNDERTAKEN. HTL-STREFA HAS BEEN CONDUCTING CORRECTIVE ACTIONS AIMED AT THE ELIMINATION OF THIS PROBLEM AND COMMUNICATING THE DETAILS TO ARKARAY. CAPA COVERED: CHANGE OF THE NEEDLE INJECTION MOLDING PROCESS AND THE NEW RESISTANT RAISIN MIX WAS CHANGED. CHANGE IN THE FINISH PRODUCT RELEASE - CURRENTLY, THE PRODUCE IS BEING CONTROLLED AFTER MOLDING STAGE AND AFTER IRRADIATION TOO, THE RESPECTIVE INSTRUCTIONS WERE AMENDED FOR IN-PROCESS AND FINISHED PRODUCT RELEASE CONTROLS. HTL DID NOT RECEIVE ANY COMPLAINTS REGISTERED FOR THE DEVICES PRODUCED AFTER IMPLEMENTATION OF CAPA. THE MALFUNCTION IS STILL UNDER MONITORING.

    Description of Event or Problem · 1

    (B)(4), RECEIVED A LETTER FROM (B)(6) FROM (B)(6) IN REFERENCE TO CLAIM # (B)(4). THIS CLAIM STATED THAT EMPLOYEE MS (B)(6) RECEIVED A PUNCTURE WOUND FROM A LANCET THAT DID NOT RETRACT FOR PRODUCT # (B)(4). THE LETTER STATED THAT DUE TO THE PUNCTURE THE EMPLOYEE WAS EXPOSED TO THE (B)(6) VIRUS AS THE PT SHE WAS ATTENDING TO CARRIES THE VIRUS. MS. (B)(6) WAS REQUIRED TO UNDERGO TESTING BY AN INFECTIOUS DISEASE DOCTOR AND HAS COMPLETED TREATMENT. ARKRAY HAS ATTEMPTED TO GATHER FURTHER INFO, BUT REPORTER AND PT HAVE NOT RESPONDED WITH FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAEMOLANCE LANCET LANCET FMK HTL-STREFA S.A. 990500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening