BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORMAL I.V. FLUSH SYRINGES

    MDR report key: 1878849 · Received October 21, 2010

    Report

    Report Number
    1423982-2010-00019
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    February 9, 2010
    Report Date
    September 8, 2010
    Manufacturer
    MEDEFIL, INC.
    Product Code
    NGT
    PMA / PMN Number
    K020999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE INVESTIGATION ASSOCIATED WITH THE COMPLAINT REVEALED NO CONDITIONS OR REPORTS THAT SHOWED THAT OUR MANUFACTURING PROCESSES EITHER CAUSED OR CONTRIBUTED TO THESE FAILURE MODES. BASED ON COMMUNICATIONS WITH SOME OF THE COMPLAINANTS, IT IS BELIEVED THAT THIS ISSUE IS CAUSED BY THE ASPIRATION TECHNIQUE EMPLOYED. IT WAS DISCOVERED THAT THE COMPLAINANTS ARE USING ONE HAND TO DRAW THE PLUNGER BACK RATHER THAN TWO HANDS WHEN ASPIRATING THE SYRINGE. SINCE WE BELIEVE THAT THE COMPLAINTS RECEIVED WERE ATTRIBUTED TO THE ASPIRATION TECHNIQUE EMPLOYED BY THE USER, THE "DIRECTION FOR USE" SECTION OF THE PRODUCT INSERT WILL BE MODIFIED FOR BOTH HEPARIN AND NORMAL SALINE PRODUCTS TO CLARIFY THE PROPER ASPIRATION TECHNIQUE, WHICH INVOLVES A TWO HANDED TECHNIQUE WITH ONE HAND ON THE SYRINGE BARREL AND THE OTHER ON THE PLUNGER. THE REVISED PRODUCT INSERT WILL NOW CONTAIN THE FOLLOWING STATEMENT: "WHEN ATTEMPTING TO ASPIRATE TUBING OR AN INDWELLING DEVICE BY PULLING BACK ON SYRINGE PLUNGER, WHILE ATTACHED TO THE TUBING OR INDWELLING DEVICE, USE A TWO-HANDED TECHNIQUE WITH ONE HAND ON THE SYRINGE BARREL AND THE OTHER ON THE PLUNGER. PULL THE PLUNGER STRAIGHT BACK. DO NOT PULL OR BEND THE PLUNGER SIDEWAYS".

    Description of Event or Problem · 1

    ON (B)(6) 2010 MEDEFIL, INC. RECEIVED A COMPLAINT FROM MR. (B)(6). ACCORDING TO MR. (B)(6) HIS I.V. TEAM EVALUATED THE NORMAL SALINE I.V. FLUSH SYRINGES AND FOUND THAT AIR WAS COMING BACK INTO THE SYRINGES WHEN THE PLUNGER WAS PULLED BACK. THE AIR WOULD COME AROUND THE LL END. ALSO ONE COMPLAINT STATED THE PLUNGER PULLED OUT. ADDITIONALLY, THE SYRINGE ARE DIFFICULT TO GET OUT OF THE PLASTIC WRAPPERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORMAL I.V. FLUSH SYRINGES NORMAL I.V. FLUSH SYRINGES NGT MEDEFIL, INC. NA S09349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other