BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PREFILL

    MDR report key: 1699584 · Received May 20, 2010

    Report

    Report Number
    3002859087-2010-00125
    Event Type
    Malfunction
    Date Received
    May 20, 2010
    Report Date
    May 18, 2010
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 05/19/2010. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. AS REPORTED TO COVIDIEN BY ANOTHER MANUFACTURER, THE ATTORNEY ALLEGES THAT THE PATIENT RECEIVED DELIVERIES OF LOTS 7102784, 7102804, AND 8010064 BETWEEN (B)(6) 2007 AND (B)(6) 2008. IT WAS UNKNOWN WHETHER THE PATIENT USED ANY OR ALL OF THE LOTS. ON (B)(6) 2007, THE PATIENT RECEIVED HEPARIN SODIUM SOLUTION FLUSHES FOR MAINTENANCE OF THE LINE FOR TPN AND VANCOMYCIN ADMINISTRATION. IMMEDIATELY UPON ADMINISTRATION, THE PATIENT EXPERIENCED HYPOTENSION, NIGHT SWEATS, HEMOPTYSIS, FEVER, DISORIENTATION, DIZZINESS, LIGHT HEADEDNESS, SPEECH IMPAIRMENT, LOSS OF SENSATION, LOSS OF MOVEMENT, INCAPACITATING WEAKNESS, NAUSEA, VOMITING, ANOREXIA, CHILLS, SHORTNESS OF BREATH, LIP BLISTERS, ABDOMINAL PAIN, BILIOUS EMESIS, THRUSH, LEUKOCYTOPENIA, SEPSIS, LETHARGY, FEVER, MALNUTRITION, ANEMIA, HANDS AND ANKLES SWELLING, HYPERCALCEMIA, HYPERGLYCEMIA, ATROPHIC GASTRITIS WITHOUT HEMORRHAGE, PNEUMONIA, DYSURIA, PERFORATED VISCUS, RESPIRATORY FAILURE, EXTENSIVE INFLAMMATORY PROCESS WITHIN THE BOWEL, FUNGEMIA, PLEURAL EFFUSION, CONSTIPATION, HYPOXEMIA, PERITONEAL ADHESIONS, MULTI-ORGAN SYSTEM FAILURE, MYCOSES, MRSA, CITROBACTEREMIA, AND INSOMNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PREFILL HEPARIN PREFILL NZW COVIDIEN UNK PREFILL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1