BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PREFILL

    MDR report key: 2000020 · Received February 17, 2011

    Report

    Report Number
    3002859087-2011-00003
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    October 1, 2007
    Report Date
    February 8, 2011
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 02/17/2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    ON (B)(6) 2011 COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. THE ATTORNEY ALLEGES THAT ON OR AROUND (B)(6) 2007, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A SUPERFICIAL FEMORAL ARTERY AND POPLITEAL OCCLUSION. AS PART OF THE TREATMENT, THE PATIENT RECEIVED SEVERAL DOSES OF HEPARIN BEGINNING ON OR AROUND (B)(6) 2007 AND CONTINUING TO (B)(6) 2007. THE PATIENT WAS ADMINISTERED DOSES OF HEPARIN INCLUDING, BUT NOT LIMITED TO, HEPARIN INJECTION 1,000 U/ML FROM 10 ML VIALS, HEPARIN 20,000 UNITS IN A DEXTROSE SOLUTION FROM A 500 ML BAG, 5760 UNITS OF BOLUS HEPARIN, HEPARIN INJECTION 10,000 UNITS/ML, HEPARIN 2,000 UNITS INJECTION, HEPARIN 1,260 UNIT INFUSION, HEPARIN 1,300 UNIT INFUSION, HEPARIN 1000 UNITS INJECTION, AND HEPARIN 3000 UNITS INJECTION. THE ATTORNEY ALLEGES, SUBSEQUENT TO BEING ADMINISTERED THE HEPARIN PRODUCTS, THE PATIENT'S PLATELET COUNT DECREASED DRAMATICALLY FROM 250,000 ON (B)(6) 2007 TO 98,000 ON (B)(6) 2007. THE PATIENT WAS DIAGNOSED WITH HIT AND DEVELOPED SEVERE HIT RELATED INJURIES INCLUDING BUT NOT LIMITED TO; GRAFT THROMBOSIS, CLOTTING OF THE BLOOD, CYANOSIS OF THE EXTREMITIES, AND NECROSIS OF THE EXTREMITIES. THE PATIENT ALSO SUFFERED HEAD AND NECK FRACTURES, AND ULTIMATELY REQUIRED A GUILLOTINE BELOW THE KNEE AMPUTATION AND REQUIRED PROLONGED REHABILITATION.

    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 UNK Other| R| S