BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEAL-AWAY INTRODUCER KIT, 9F, 14CM

    MDR report key: 2823593 · Received August 1, 2008

    Report

    Report Number
    2182269-2008-00389
    Event Type
    Malfunction
    Date Received
    August 1, 2008
    Date of Event
    June 29, 2006
    Report Date
    August 1, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION PROVIDED, THE CAUSE FOR THE REPORTED LEAKING AND DIFFICULTY WITH THE VALVE FITTING PROPERLY REMAIN UNKNOWN. CORRECTIVE ACTION WAS INITIATED TO ADDRESS TEARS IN THE HEMOSTASIS SEAL OF THE INTRODUCERS.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE VALVE LEAKED AND THERE WAS A BACKFLOW OF BLOOD. THE VALVE REPORTEDLY DID NOT FIT PROPERLY. THERE WERE NO PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEAL-AWAY INTRODUCER KIT, 9F, 14CM SEAL-AWAY INTRODUCER KIT, 9F DYB ST. JUDE MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK