BEUDAMED
    FDA Adverse Event Other Summary report: N

    EZ HUBER SAFETY INFUSION SET

    MDR report key: 1416621 · Received April 17, 2009

    Report

    Report Number
    2032582-2009-00005
    Event Type
    Other
    Date Received
    April 17, 2009
    Date of Event
    March 17, 2009
    Report Date
    April 17, 2009
    Manufacturer
    PFM MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K071846
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTED TO OBTAIN ADD'L INFO FROM DISTRIBUTOR AND FACILITY. EMAILED OR CALLED DISTRIBUTOR ON THE FOLLOWING DATES: 3/17 (CALL), 3/23, 3/23 (CALL), 3/24, 3/26, 3/31 CALLS MADE DIRECTLY TO FACILITY 3/31, 4/1, 4/7, 4/13, 4/14, 4/15, 4/16, 4/17. MULTIPLE ATTEMPTS MADE TO DISTRIBUTOR AND FACILITY TO COLLECT NECESSARY INFO TO INVESTIGATE EVENT. UNABLE TO OBTAIN ADD'L INFO. STERILIZATION REVIEW. STERILIZATION VALIDATION FOR 4TH QTR 2008 AND 1ST QTR 2009 WERE REVIEWED AND FOUND TO BE IN ORDER. ENVIRONMENTAL MEDIA PLATES FOR 4TH QTR 2008 AND 1ST QTR 2009 WERE REVIEWED AND FOUND TO BE IN ORDER. REVIEW OF ALL PRODUCTION STERILIZATION BATCH RUNS INDICATED THE MINIMUM DOSE REQUIREMENTS WERE MET ON EACH PRODUCTION RUN. LABEL REVIEW: IFU STATES, "USE ASEPTIC TECHNIQUE". METHOD: NO SAMPLE RETURNED FOR INVESTIGATION. RESULTS: REVIEWED STERILIZATION, ENVIRONMENTAL CONTROLS AND LABELING. INSUFFICIENT INFORMATION TO PROPERLY INVESTIGATE COMPLAINT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADD'L INFO. STERILIZATION AND ENVIRONMENTAL CONTROLS WERE REVIEWED AND FOUND TO BE IN ORDER. CLOSED COMPLAINT DUE TO INSUFFICIENT INFORMATION. (B)(6).

    Description of Event or Problem · 1

    FACILITY REPORTS THAT THREE SEPARATE LINE INFECTIONS OCCURRED DURING THE USE OF THE EZ HUBER. FACILITY HAD NOT EXPERIENCED THIS PROBLEM BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ HUBER SAFETY INFUSION SET ADMINISTRATION SET FPA PFM MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1