BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRM PB W/YLW KEY SC 3CLV BC AND OL

    MDR report key: 3905811 · Received May 29, 2014

    Report

    Report Number
    9615050-2014-03731
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 5, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE AND ONE USED NEEDLELESS VALVE CONNECTOR WERE REC'D AND EVALUATED. TESTING FOUND THAT THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER WAS BROKEN OFF INSIDE THE NEEDLELESS VALVE CONNECTOR. DRAG MARKS WERE NOTED ON THE TIP OF THE OPTION-LOK MALE ADAPTER INDICATING APPLICATION OF EXCESSIVE 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 THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BREAKAGE OF THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO AN UNSPECIFIED NEEDLELESS VALVE CONNECTOR CONNECTED TO THE PATIENT'S IV AND WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE. NO SPECIFIC DETAILS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED WHEN THE NURSE DISCONNECTED THE OPTION-LOK MALE ADAPTER FROM THE NEEDLELESS VALVE CONNECTOR, THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER BROKE OFF AND A PIECE REMAINED LODGED INSIDE THE NEEDLELESS ADAPTER. THE TUBING SETS WERE REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO DELAY IN THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317414 PRM PB W/YLW KEY SC 3CLV BC AND OL 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MICROCLAVE CLEAR CONNECTOR, LIST 12512, LOT UNK,| MANUFACTURED BY ICU MEDICAL, INC.