BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE PORT MICRO EXTENSION SET - 7" INT

    MDR report key: 1181645 · Received September 30, 2008

    Report

    Report Number
    9613251-2008-00350
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 4, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K953584
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK; SUBSEQUENTLY, BLEED BACK WAS NOTED. IT WAS REPORTED THE TUBING SET WAS FLUSHED USING A 3ML SYRINGE VIA THE CLAVE PORT. AN UNSPECIFIED TUBING SET WAS THEN CONNECTED TO THE CLAVE PORT FOR DELIVERY OF AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS NOTED THAT THE SOLUTION WAS LEAKING FROM THE CONNECTION OF THE CLAVE PORT AND THE TUBING SET AND AN UNSPECIFIED VOLUME OF BLOOD BACKED UP INTO THE TUBING. THE TUBING SETS WERE REPLACED AND THE THERAPY WAS RESUMED. UPON DISCONNECTING THE TUBING SET FROM THE CLAVE PORT, IT WAS NOTED THAT THE SILICONE SLEEVE OF THE CLAVE REMAINED DEPRESSED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVE PORT MICRO EXTENSION SET - 7" INT 80-FPA FPA HOSPIRA LTD. NA 59039NS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 3ML SYRINGE: LOT#812711A| UNSPECIFIED PLUMSET: LIST#UNK