BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS CLAVE PORT EXT 7"

    MDR report key: 1071367 · Received July 8, 2008

    Report

    Report Number
    9613251-2008-00247
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 10, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K915571
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A HOLE IN THE TUBING; SUBSEQUENTLY, BLOOD LOSS WAS NOTED. THE PT WAS TRANSFERRED TO THE CATH LAB FOR AN UNSPECIFIED PROCEDURE. THE ECHO TECHNICIAN REPORTED THAT WHEN THE PT ARRIVED IN THE DEPT, THE IV SITE APPEARED INFILTRATED. IT WAS REPORTED THAT WHILE THE TECHNICIAN WAS ATTEMPTING TO FLUSH THE TUBING WITH AN UNSPECIFIED SOLUTION, A "LARGE HOLE" IN THE TUBING WAS NOTED AND AN UNSPECIFIED AMOUNT OF BLOOD LOSS WAS REPORTED. THE TUBING SET WAS CLAMPED. THE TUBING SET AND IV CATHETER WERE REPLACED AND THE PROCEDURE WAS INITIATED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS CLAVE PORT EXT 7" 80-FPA FPA HOSPIRA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1