BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH SAFETY LANCETS LOW FLOW

    MDR report key: 17406381 · Received July 27, 2023

    Report

    Report Number
    8021764-2023-00004
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    June 5, 2023
    Report Date
    August 9, 2023
    Manufacturer
    OWEN MUMFORD LIMITED
    Product Code
    FMK
    UDI-DI
    20885380065955
    PMA / PMN Number
    K221126
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RN CONTACT DETAILS WERE NOT GIVEN TO OWEN MUMFORD. WE HAVE HAD TO RELY ON CARDINAL HEALTH TO OBTAIN MORE INFORMATION AND NONE HAS BEEN PROVIDED. OM INC FOLLOWED UP THREE TIMES TRYING TO OBTAIN A MEDICAL QUESTIONNAIRE AND ONE WAS NOT RETURNED.

    Description of Event or Problem · 0

    OMI'S CUSTOMER CARDINAL HEALTH EMAILED THEIR EVENT FORM TO REPORT THEIR CUSTOMER, (B)(6)HOSPITAL HAD A LANCET NOT RETRACT AFTER USING ON A FINGERSITCK AND AS A RESULT THE RN PERFORMING THE PROCEDURE WAS STUCK WITH THE USED NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671826 CARDINAL HEALTH SAFETY LANCETS LOW FLOW LANCET FMK OWEN MUMFORD LIMITED AT 6204 05919 20885380065955

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other