BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE PRO SYRINGE AND NEEDLE WITH NEEDLE PROTECT

    MDR report key: 865448 · Received September 25, 2006

    Report

    Report Number
    1217052-2006-00073
    Event Type
    Malfunction
    Date Received
    September 25, 2006
    Date of Event
    June 1, 2006
    Report Date
    August 30, 2006
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SAME PT ALSO REPORTED USING LOT NUMBER K661347; EXPIRATION DATE 04/2010 IN 2006. EVALUATIONS: THE INVESTIGATION IS BASED ON HISTORICAL DATA AND REVIEW OF THE DEVICE LOT INFORMATION. A REVIEW OF THE COMPLAINTS DATABASE REVEALS NO SIMILAR REPORTS OF ABSCESS WHILE USING OUR NEEDLE. A REVIEW OF MFG AND STERILIZATION RECORDS, FOR THE REPORTED LOTS, REVEALS THAT ALL RECORDS WERE WITHIN SPECIFICATION. DUE TO NO SIMILAR REPORTS REC'D, NO PROBLEMS DURING MFR, THERE IS NO WAY TO DETERMINE THAT THE NEEDLE IN THESE LOTS WAS THE CAUSE OF THE REPORTED ABSCESS.

    Description of Event or Problem · 1

    USER ALLEGES THAT THEY HAD A PT THAT HAS BEEN HAVING INJECTIONS FOR 2.5 YEARS. THE PT RECEIVED INJECTIONS IN 2006 AND THE FOLLOWING MONTH, AND DEVELOPED AN ABSCESS THAT THEY FEEL IS DUE TO OUR NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPODERMIC NEEDLE PRO SYRINGE AND NEEDLE WITH NEEDLE PROTECT 80 FMI - ACCESSORY TO HYPODERMIC NEEDLES FMI SMITHS MEDICAL ASD, INC. NA K653575

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO