BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS CLAVE PORT EXT 7"

    MDR report key: 1211247 · Received October 16, 2008

    Report

    Report Number
    9613251-2008-00365
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 23, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K915571
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICES WERE DISCARDED. THE INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF THE CLAVE PORTS REMAINING IN THE OPEN POSITIONS; SUBSEQUENTLY, BLEED BACK WAS NOTED. THE CLAVE PORTS OF THE TUBING SETS WERE BEING ACCESSED BY UNSPECIFIED ACCESS DEVICES. THE CUSTOMER CONTACT REPORTED THAT UPON REMOVAL OF THE ACCESS DEVICES, THE SILICONE SLEEVES OF THE CLAVES DID NOT "BOUNCE BACK" TO THE CLOSED POSITION AND BLEED BACK WAS NOTED. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS CLAVE PORT EXT 7" 80-FPA FPA HOSPIRA LTD. NA 66043NS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK