BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEPARIN I.V. FLUSH SYRINGE 100 UNITS/ML

    MDR report key: 1032499 · Received April 21, 2008

    Report

    Report Number
    1423982-2008-00002
    Event Type
    Other
    Date Received
    April 21, 2008
    Report Date
    April 2, 2008
    Manufacturer
    MEDEFIL, INC.
    Product Code
    NZW
    PMA / PMN Number
    020996
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLETED A COMPREHENSIVE BATCH REVIEW OF BOTH LOTS OF HEPARIN I.V. FLUSH SYRINGE 100 UNITS/ML, 5 ML FILL IN 12 ML SYRINGE AND NO ANOMALIES WERE REPORTED DURING BATCH PRODUCTION. ALL INITIALS, IN-PROCESS, AND FINAL TESTING RESULTS WERE ACCEPTABLE AND WITHIN NORMAL LIMITS FOR BOTH THE LOTS. ONCE THE REPORT WAS RECEIVED, RETAINED SAMPLES OF LOT NUMBERS H107301 AND H107305 WERE TESTED FOR STERILITY PER USP CHAPTER <71> STERILITY TESTS. SYRINGES FROM LOT H107301 WERE ALSO RECEIVED FROM THE PATIENTS HOME AND WERE ALSO TESTED FOR STERILITY PER USP CHAPTER <71> STERILITY TESTS. THERE WAS NO GROWTH BOTH ON TRYPTIC SOY BROTH AND FLUID THIOGLYCOLLATE MEDIA AFTER 14 DAYS OF INCUBATION FOR ALL THREE TESTS. (RETAINED SAMPLES FOR LOT H107301, H107305 AND SAMPLES OF LOT H107301 RECEIVED FROM THE PATIENTS HOME). BATCH RECORDS FOR THREE PRODUCT LOTS PRODUCED PRE AND POST LOT NUMBERS H107301 AND H107305 WERE ALSO REVIEWED. THERE WERE NO ANOMALIES REPORTED DURING THE PRODUCTION OF THESE LOTS EITHER. ALL RETAINED SAMPLES FOR THESE LOTS WERE ALSO EXAMINED, AND THERE WERE NO DEFECTS OR DISCOLORED SOLUTION OBSERVED IN ANY OF THE RETAINED SAMPLES. ADD'L LOT# H107305.

    Description of Event or Problem · 1

    RECEIVED PHONE CALL IN 2008 THAT TWO LOTS OF HEPARIN I.V. FLUSH SYRINGE, 100 UNITS/ML, 5 ML FILL IN 12 ML SYRINGE MIGHT BE CONTAMINATED. PER THE PHARMACIST. WHEN THE PT WAS NOTIFIED OF THE RECALL OF THE HEPARIN I.V. FLUSH SYRINGES (DUE TO RECALL BY API MFR OF POSSIBLE CHEMICAL CONTAMINATION), THE PT COMPLAINED THAT SHE HAD INFECTIONS IN THE PAST USING THESE TWO LOTS AND REFUSED TO GIVE THE INFO ABOUT THE INFECTIONS OR THE NATURE OF THE INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN I.V. FLUSH SYRINGE 100 UNITS/ML PREFILLED 5ML IN 12 ML SYRINGE NZW MEDEFIL, INC. 64253-333-35 H107301

    Patients

    Seq Age Sex Outcome Treatment
    1