BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3970721 · Received April 29, 2014

    Report

    Report Number
    9615050-2014-03088
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 3, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RECEIVED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER CONTACT IDENTIFIED ONE POSSIBLE LOT NUMBER (PLOTS). THE POSSIBLE LOT NUMBER IS 360115H. HOSPIRA HAS COMPLETED A FORMAL INVESTIGATION TO ADDRESS THE ISSUE BREAKAGE OF THE CLAVE SECONDARY PORT. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT THE DEVICE BREAKAGE WAS DUE TO THE DESIGN OF CLAVE PORT THAT IS DIRECTLY BONDED TO THE SECONDARY PORT OF THE CASSETTE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED DEVICE BREAKAGE; SUBSEQUENTLY, A LEAK WAS NOTED. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF VANCOMYCIN, AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT DURING PRIMING PRIOR TO PATIENT USE, THE NURSE REPORTED THAT 10ML OR LESS OF SOLUTION LEAKED ONTO THE FLOOR. DURING VISUAL EXAMINATION BY THE NURSE AT THE USER FACILITY, IT WAS NOTED THAT THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE TUBING SET WAS BROKEN. NO SPECIFIC DETAILS WERE PROVIDED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255524 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA