BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECNDRY SET 34IN NDEH W/EXT HOOK

    MDR report key: 3883200 · Received May 23, 2014

    Report

    Report Number
    9613251-2014-00104
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED AND EVALUATED. THE DEVICE PASSED TESTING. NO LEAKS OF SOLUTION WERE NOTED DURING THE TESTING PROCEDURES. ALTHOUGH THE DEVICE PASSED TESTING, HOSPIRA HAS COMPLETED A FORMAL INVESTIGATION TO ADDRESS SIMILAR COMPLAINTS DUE TO SPIN COLLAR OPTION-LOK CONNECTION PROBLEMS WITH OTHER DEVICES WHICH RESULTED IN LEAKS, CRACKS AND GENERAL CONNECTIONS EVENTS. BASED UPON THE INVESTIGATION RESULTS, HOSPIRA HAS IDENTIFIED THAT IT NEEDS TO MAKE DIMENSIONAL CHANGES TO THE SPIN COLLAR THAT WILL IMPROVE THE COMPLIANCE WITH THE ISO STANDARD (594-2) AND INTERACTION WITH OTHER COMPONENTS. THE PLANNED IMPROVEMENTS WILL OPTIMIZE THE DESIGN OF THE THREAD, MINIMIZE IDENTIFIED FAILURE MODES AND RESULTANT COMPLAINTS. THE INTERNATIONAL AFFILIATE WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED. NO RESPONSE HAS BEEN RECEIVED. 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 A LEAK. A PLUMSET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE MALE ADAPTER OF THE SECONDARY TUBING SET WAS CONNECTED TO THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT WHEN THE SECONDARY TUBING SET WAS CONNECTED TO THE CLAVE SECONDARY PORT, A LEAK OF SOLUTION WAS NOTED. NO SPECIFIC DETAILS WERE PROVIDED. THE LOCATION OF THE LEAK WAS DESCRIBED AS AT THE TOP OF THE CLAVE SECONDARY PORT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309082 SECNDRY SET 34IN NDEH W/EXT HOOK 80FPA FPA HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PRIMARY PLUMSET, LIST #14687, LOT #UNK