BEUDAMED
    FDA Adverse Event Summary report: N

    SOL-M BLUNT FILL NEEDLE

    MDR report key: 4921494 · Received July 15, 2015

    Report

    Report Number
    3008863617-2015-00002
    Date Received
    July 15, 2015
    Date of Event
    March 12, 2015
    Report Date
    July 16, 2015
    Manufacturer
    SOL-MILLENNIUM MEDICAL, INC.
    Product Code
    LHI
    PMA / PMN Number
    K0838501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE QUALITY INSPECTION REPORTS REVEALED NO INDICATIONS OF IRREGULARITIES FOR THE REPORTED LOT NUMBER 4072136. IF A SAMPLE CAN BE OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    OCCLUDED BLUNT NEEDLES PREVENTING MEDICATION TO BE DRAWN UP. CONCERN IS THAT THESE BLUNT NEEDLES MAY HAVE PARTICULATE MATTER THAT COULD POTENTIALLY BE INJECTED INTO A PATIENT'S BLOODSTREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460653 SOL-M BLUNT FILL NEEDLE SYRINGE CANNULA, 80 LHI LHI SOL-MILLENNIUM MEDICAL, INC. 141027

    Patients

    Seq Age Sex Outcome Treatment
    1