BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP 2CLV YSTE MACR

    MDR report key: 3820491 · Received April 9, 2014

    Report

    Report Number
    9613251-2014-00078
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 12, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED AND EVALUATED. TESTING FOUND THAT THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER WAS BROKEN OFF INSIDE THE DISTAL CLAVE OF THE 6" TAIL. 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. 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 OPTION-LOK MALE ADAPTER OF THE SECONDARY TUBING SET WAS CONNECTED TO THE DISTAL CLAVE Y-SITE OF THE PLUMSET FOR THE DELIVERY OF AN UNSPECIFIED VOLUME OF NORMAL SALINE AT A TO KEEP OPEN (TKO) RATE. NO SPECIFIC DETAILS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT WHILE THE NURSE WAS DISCONNECTING THE OPTION-LOK MALE ADAPTER FROM THE CLAVE Y-SITE, THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER BROKE OFF AND A PIECE REMAINED LODGED INSIDE THE DISTAL CLAVE Y-SITE. THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED VOLUME OF NORMAL SALINE LEAKED. THE TUBING SETS WERE REPLACED. THERE WERE NO REPORTS OF ADVERSE PT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THE PT. NO MEDICAL INTERVENTION WERE REQUIRED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213244 NDEHP 2CLV YSTE MACR 80FPA FPA HOSPIRA LTD. NA 340064W

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR PRIMARY PLUMSET, LIST # 12538, LOT # 360125H