BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTISEPTIC CAP

    MDR report key: 1900543 · Received October 29, 2010

    Report

    Report Number
    3005515211-2010-00007
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 19, 2010
    Manufacturer
    AMSINO MED CO. LTD., CONTRACT MFR FOR HOSPIRA INC.
    Product Code
    FPA
    PMA / PMN Number
    K080579
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK; SUBSEQUENTLY BLOOD LOSS WAS NOTED. THE DEVICE WAS CONNECTED TO THE NEEDLELESS INJECTION CAP ON A POWERPICC CATHETER. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED AN UNSPECIFIED VOLUME OF BLOOD LEAKING FROM THE THREADS OF THE DEVICE AND THE NEEDLELESS CAP. THE NURSE REMOVED THE DEVICE AND FLUSHED THE CATHETER. THE DEVICE WAS REPLACED WITH A CLAVE PORT. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTISEPTIC CAP 80LKB FPA AMSINO MED CO. LTD., CONTRACT MFR FOR HOSPIRA INC. NA 80601KY

    Patients

    Seq Age Sex Outcome Treatment
    1 POWERPICC CATHETER, MFG BY BARD ACCESS SYSTEMS