BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEPARIN PREFILL UNKNOWN

    MDR report key: 1031067 · Received April 15, 2008

    Report

    Report Number
    3002859087-2008-00009
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 10, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE 4/14/2008. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION, THE RESULTS WILL BE FORWARDED. THESE REPORTS ARE BEING FILED IN ACCORDANCE TO THE APRIL 8TH FDA GUIDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON 4/10/2008, THAT A CUSTOMER HAD AN ISSUE WITH THE HEPARIN PREFILLED SYRINGE. THE CUSTOMER REPORTS, THAT HE IS UNSURE WHAT THE CATALOG NUMBER OR LOT NUMBER IS, AS HE HAS SENT HIS SUPPLY BACK PER THE DIRECTION OF HIS DISTRIBUTOR. THE CUSTOMER REPORTS, HE HAS A PICC LINE IN FOR COPD. HE RECEIVED HEPARIN THROUGH THIS LINE AND INSTANTLY FELT SOB AND HAD A RAPID HEART RATE. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN PREFILL UNKNOWN HEPARIN PREFILLED SYRINGE NZW TYCO HEALTHCARE/KENDALL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK