BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTISEPTIC CAP

    MDR report key: 1900541 · Received October 29, 2010

    Report

    Report Number
    3005515211-2010-00006
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 7, 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 DEVICES WERE DISCARDED. THE DEVICES WERE NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICES 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

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF LEAKING; SUBSEQUENTLY BLOOD LOSS WAS NOTED. THE DEVICES WERE CONNECTED TO THE NEEDLELESS INJECTION CAPS ON THE POWERPICC CATHETERS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE NURSES NOTED UNSPECIFIED VOLUMES OF BLOOD LEAKING FROM THE THREADS OF THE DEVICES AND THE NEEDLELESS INJECTION CAPS. THE NURSES REMOVED THE DEVICES AND FLUSHED THE CATHETERS. THE DEVICES WERE REPLACED WITH CLAVE PORTS. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS OF THERAPIES CRITICAL TO THESE PATIENTS. 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 CATHETERS, MFG BY BARD ACCESS SYSTEMS