BEUDAMED
    FDA Adverse Event Other Summary report: N

    NORMAL SALINE I.V. FLUSH SYRINGES

    MDR report key: 1879577 · Received October 21, 2010

    Report

    Report Number
    1423982-2010-00020
    Event Type
    Other
    Date Received
    October 21, 2010
    Date of Event
    January 1, 2009
    Report Date
    September 14, 2010
    Manufacturer
    MEDEFIL, INC.
    Product Code
    NGT
    PMA / PMN Number
    K020999
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR FAILURE INVESTIGATION CONCLUDED THAT OUR MANUFACTURING PROCESSES DID NOT CAUSE OR CONTRIBUTE TO CONTAMINATION OF THE SYRINGE. WE HAVE REQUESTED AN INVESTIGATION AT OUR SUPPLIER LEVEL. THEY PROPOSED THAT THE SET-UP, MAINTENANCE AND CALIBRATION OF THEIR IN-LINE METAL DETECTOR WOULD NEED TO BE RE-ASSESSED. WE WILL CONTINUE TO MONITOR WITH SUPPLIER UNTIL THEY COMPLETE THEIR ACTION PLAN.

    Description of Event or Problem · 1

    ON (B)(6) 2009, RECEIVED COMMUNICATION FROM MEDEFIL'S VP SALES AND MARKETING THAT THE (B)(6), RECEIVED A COMPLAINT ON (B)(6) 2009, FROM A VISITING NURSE STATING THAT (B)(6) 2009, SHE HAD COLLECTED A 5 ML SALINE FLUSH SYRINGE AT A PATIENT'S HOME SHOWING A FOREIGN MATTER AND DISCOLORATION. THE SYRINGE WAS RETURNED TO MEDEFIL FOR INVESTIGATION. ON (B)(6) 2010, MEDEFIL RECEIVED A DRUG QUALITY REPORTING (DQR), (B)(4) ALERTING MEDEFIL OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORMAL SALINE I.V. FLUSH SYRINGES NORMAL SALINE I.V. FLUSH SYRINGES NGT MEDEFIL, INC. NA S09278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA