BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBORE EXT SET 60IN NDEHP

    MDR report key: 2498001 · Received March 15, 2012

    Report

    Report Number
    9613251-2012-00040
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 16, 2012
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED DEVICE BREAKAGE; SUBSEQUENTLY BLEED BACK WAS NOTED. AN UNSPECIFIED PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION. AT AN UNSPECIFIED TIME, THE MICROBORE MALE ADAPTER OF THE EXTENSION SET WAS CONNECTED TO A MICROCLAVE PORT AT AN UNSPECIFIED LOCATION ON THE PRIMARY SET FOR A DELIVERY OF AN UNSPECIFIED MEDICATION. IT WAS REPORTED THAT AFTER ONE HOUR IN USE, WHILE THE NURSE DISCONNECTED THE EXTENSION SET FROM THE MICROCLAVE PORT, THE MALE ADAPTER OF THE EXTENSION SET BROKE OFF IN THE MICROCLAVE PORT. AN UNSPECIFIED VOLUME OF BLEED BACK INTO THE PRIMARY TUBING SET WAS NOTED. THE PRIMARY TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIBORE EXT SET 60IN NDEHP 80FPK FPK HOSPIRA LTD. NA 08117NS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED PRIMARY TUBING SET,LIST #UNK, LOT #UNK