BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 2781800 · Received October 5, 2012

    Report

    Report Number
    9615050-2012-01194
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 7, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT 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 (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 INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF DISCONNECTIONS. ON UNSPECIFIED DATES, THE OPTION-LOK MALE ADAPTER OF THE TUBING SETS WERE CONNECTED TO THE HUB OF AN UNSPECIFIED IV CATHETER AND WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS VIA PLUM PUMPS. AFTER UNSPECIFIED LENGTHS OF TIME, IT WAS REPORTED THAT THE OPTION-LOK MALE ADAPTER OF THE TUBING SETS DISCONNECTED FROM THE HUB OF THE IV CATHETERS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS OF THERAPIES CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THE TUBING SETS WERE REPLACED AND THE THERAPIES RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FPA FPA HOSPIRA COSTA RICA LTD. NA 153065H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED IV CATHETERS: MFR UNK