BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIF MK W/DT4 W/SS 84

    MDR report key: 1470420 · Received August 3, 2009

    Report

    Report Number
    9615050-2009-00170
    Event Type
    Malfunction
    Date Received
    August 3, 2009
    Date of Event
    July 1, 2009
    Report Date
    July 21, 2009
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    DRS
    PMA / PMN Number
    K932188
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICES WERE DISCARDED. A REP DEVICE FROM THE SAME LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. (B) (4). (B) (4).

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF CRACKS; SUBSEQUENTLY LEAKS WERE NOTED. THE MONITORING KITS WERE BEING USED TO DELIVER UNSPECIFIED SOLUTIONS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, IT WAS REPORTED THAT THE MONITORING KITS WERE "SPONTANEOUSLY BREAKING BETWEEN THE TRANSDUCER AND THE STOPCOCK." IT WAS REPORTED THAT FLUID LEAKED FROM THE CRACKS AND IN SOME CASES UNSPECIFIED VOLUMES OF BLEEDBACK WAS ALSO NOTED. THE MONITORING KITS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIF MK W/DT4 W/SS 84 74KRA DRS HOSPIRA COSTA RICA LTD. NA 714115G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK