BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEPARIN I.V. FLUSH SYRINGE

    MDR report key: 1824575 · Received September 2, 2010

    Report

    Report Number
    1423982-2010-00005
    Event Type
    Death
    Date Received
    September 2, 2010
    Date of Event
    November 1, 2007
    Report Date
    August 24, 2010
    Manufacturer
    MEDEFIL, INC.
    Product Code
    NZW
    PMA / PMN Number
    K020996
    Removal / Correction Number
    Z-1543/1545-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RELEASED FOR COMMERCIAL DISTRIBUTION FOLLOWING THE RELEASE TESTING CRITERIA FOR HEPARIN LOCK FLUSH SOLUTION, (B)(6) MONOGRAPH. THIS LOT WAS RECALLED DUE TO OVER SULFATED CHONDROITIN SULFATE (OSCS) CONTAMINATION OF HEPARIN SODIUM, RECALL NUMBER Z-1543/1545-2008. THE SIDE EFFECTS OF OSCS ARE; NAUSEA, VOMITING AND SHORTNESS OF BREATH. PT'S FEELING THE SYMPTOMS DETAILED ABOVE FOLLOWING ADMINISTRATION OF HEPARIN I.V. RECALL HAS BEEN COMPLETED AND CLOSED AS ACKNOWLEDGED BY FDA ON LETTER DATED APRIL 15, 2010.

    Description of Event or Problem · 1

    (B)(4), INITIATED BY PT'S ATTORNEY WITH A "DATE OF EVENT" OF (B)(6)2007 AND (B)(4). THE FILED MDR PROVIDED THE FOLLOWING EVENT INFO BASED ON THE 01/11/2010 UPDATE: FROM (B)(6) 2007 TO (B)(6) 2007, THE PT WAS TREATED WITH HEPARIN SODIUM INJECTION THERAPY ( /(B)(4)) IV 100 U/ML 5ML, LOT NUMBERS 7051544, AND 7102804. IN (B)(6) 2008, THE PT WAS TREATED WITH HEPARIN SODIUM INJECTION THERAPY (MEDEFIL, INC.), 100 U/ML 5 ML FILL/12ML, LOT NUMBER H107322. IN (B)(6) 2008, IMMEDIATELY AFTER ADMINISTRATION OF HEPARIN SODIUM FLUSH THERAPY, THE PT EXPERIENCED SWOLLEN FACE, AND LOSS OF APPETITE. ON (B)(6)2008, THE PT DIED. THE CAUSE OF DEATH WAS CARDIOPULMONARY ARREST, ACUTE LEUKEMIA (BLAST PHASE), SECONDARY MDB, AND ACUTE LYMPHOBLASTIC LEUKEMIA. IT WAS UNK WHETHER AN AUTOPSY WAS PERFORMED. THE HEADACHES, NAUSEA, VOMITING, LOW BLOOD PRESSURE, LETHARGY, SWOLLEN FACE, AND LOSS OF APPETITE HAD NOT RESOLVED PRIOR TO THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN I.V. FLUSH SYRINGE HEPARIN I.V. FLUSH SYRINGE NZW MEDEFIL, INC. 64253-222-35 H107322

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Death