BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 15829984 · Received November 19, 2022

    Report

    Report Number
    3017368639-2022-00033
    Event Type
    Malfunction
    Date Received
    November 19, 2022
    Date of Event
    October 26, 2022
    Report Date
    November 16, 2022
    Manufacturer
    ASKU
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MCKESSON MEDICAL-SURGICAL, INC. IS THE ASSEMBLER OF CONVENIENCE KITS THAT CONTAIN SAFETY NEEDLES AND SYRINGES AS COMPONENTS. PRODUCT IDENTIFICATION INFORMATION COULD NOT BE PROVIDED BY THE CUSTOMER, AND THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF THE DEFECTIVE COMPONENT(S) ORIGINATED FROM A CONVENIENCE KIT SUPPLIED BY MCKESSON MEDICAL-SURGICAL, INC. THE LACK OF INFORMATION ALSO IMPACTS BEING ABLE TO PROVIDE SPECIFIC INFORMATION IN SECTION D OF THIS REPORT. WE HAVE NOTIFIED (B)(6) AND (B)(6) OF THIS COMPLAINT FOR THEIR AWARENESS.

    Description of Event or Problem · 0

    HEALTHCARE PROVIDER E-MAILED STATING THAT NEEDLES WERE BENT, CRACKED, OR NOT STAYING IN PLACE WHEN ATTACHING TO SYRINGE. THE E-MAIL FROM THE PROVIDER ALSO STATED THAT THE STAFF DID NOT FEEL COMFORTABLE USING THE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345249 ASKU SAFETY NEEDLE FMI ASKU ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown