BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMSET 2 CLAVES 272CM NDEHP

    MDR report key: 2860034 · Received December 4, 2012

    Report

    Report Number
    9615050-2012-01461
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 28, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE SERVICE FACILITY, AIR WAS NOTED DISTAL TO THE CASSETTE OF THE TUBING SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY PLUMSET 2 CLAVES 272CM NDEHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA 180395H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA