BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP 3CLV YSTE MACR

    MDR report key: 1982652 · Received December 20, 2010

    Report

    Report Number
    9613251-2010-00177
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 23, 2010
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICES WERE DISCARDED. HOSPIRA HAD 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 ((B)(4)) 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 COMPLAINT. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF DISCONNECTIONS. THE OPTION-LOK MALE ADAPTERS OF THE TUBING SETS WERE CONNECTED TO UNSPECIFIED CATHETERS TO DELIVER UNSPECIFIED SOLUTIONS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE OPTION-LOK MALE ADAPTERS DISCONNECTED FROM THE CATHETERS. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS IN THERAPIES CRITICAL FOR THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP 3CLV YSTE MACR 80FPA FPA HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK