BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLD-ANIMAL HEAL

    MDR report key: 3894639 · Received May 21, 2014

    Report

    Report Number
    9615050-2014-03547
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 28, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    FA311-04
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING IT WAS NOTED THAT THE DEVICE DOOR ROLLER WAS MISSING AND THE DOOR ROLLER PIN WAS BROKEN OFF. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER FOR REMEDIATION. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS NOTED THAT THE DEVICE DOOR ROLLER WAS MISSING AND THE DOOR ROLLER PIN WAS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303947 PLUM XLD-ANIMAL HEAL 80FPA FPA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA