BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSTAR CATH LAB SET W/1050 4-GANG MANIFOLD

    MDR report key: 1003232 · Received February 21, 2008

    Report

    Report Number
    9616567-2008-00012
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 24, 2008
    Manufacturer
    SMITHS MEDICAL, ASD
    Product Code
    DRS
    PMA / PMN Number
    K942371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE PRODUCT WAS UNAVAILABLE FOR RETURN. THE CUSTOMER ALSO INDICATED THAT THE EXACT LOT NUMBER WAS UNK. THE DEVICE HISTORY COULD NOT BE REVIEWED WITHOUT A REPORTED LOT NUMBER AS A REFERENCE. SMITHS WAS UNABLE TO CONFIRM THE ISSUE OR DETERMINE A POSSIBLE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT EVAL. THIS ISSUE IS BEING MONITORED. NO ADD'L ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THERE WAS AIR IN THE LINE DURING SET UP. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSTAR CATH LAB SET W/1050 4-GANG MANIFOLD PRESSURE MONITORING SET DRS SMITHS MEDICAL, ASD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA