BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDHP 0.2 MICRN HP CL

    MDR report key: 3912717 · Received May 14, 2014

    Report

    Report Number
    9613251-2014-00103
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    February 1, 2014
    Report Date
    April 14, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K113683
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE AND ONE USED NEEDLELESS VALVE CONNECTOR WERE RECEIVED AND EVALUATED. TESTING FOUND THAT THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS BROKEN OFF INSIDE THE NEEDLELESS VALVE CONNECTOR. WHITE DRAG MARKS WERE NOTED ON THE OPTION-LOK MALE ADAPTER INDICATING APPLICATION OF FORCE ON THE MALE ADAPTER. 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, TAPER AND TAPER PROTRUSION OF THE OPTION-LOK TO MINIMIZE IDENTIFIED FAILURE MODES AND RESULTANT COMPLAINTS. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPITAL PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BREAKAGE OF THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION. THE CUSTOMER CONTACT REPORTED THAT AFTER THE DELIVERY WAS COMPLETE, THE NURSE DISCONNECTED THE TUBING SET FROM A NEEDLELESS VALVE CONNECTOR. AT THIS TIME, IT WAS REPORTED THAT THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER OF THE TUBING SET BROKE OFF INSIDE THE NEEDLELESS VALVE CONNECTOR. THE TUBING SET AND THE NEEDLELESS VALVE CONNECTOR WERE REPLACED. THERE WERE NO REPORTS OF ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THE PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THROUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288092 NDHP 0.2 MICRN HP CL 80FPA FPA HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MFR CAREFUSION CORP.| MAXPLUS VALVE CONNECTOR, LIST # UNK,