BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3802755 · Received February 21, 2014

    Report

    Report Number
    9615050-2014-01416
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 23, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED AND EVALUATED. TESTING FOUND THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE TUBING SET WAS TORN OFF. WHITE DRAG MARKS WERE NOTED ON THE SECONDARY PORT OF THE CASSETTE INDICATING USE OF FORCE. HOSPIRA HAS COMPLETED A FORMAL INVESTIGATION TO ADDRESS THE ISSUE OF DEVICE BREAKAGE OF THE CLAVE SECONDARY PORT. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT THE DEVICE BREAKAGE WAS DUE TO THE DESIGN OF CLAVE PORT THAT IS DIRECTLY BONDED TO THE SECONDARY PORT OF THE CASSETTE. 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 DEVICE BREAKAGE. THE PRIMARY TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF AN UNSPECIFIED CONCENTRATION OF SODIUM CHLORIDE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE NURSE ATTEMPTED TO CONNECT THE MALE ADAPTER OF AN UNSPECIFIED 10ML PREFILLED SALINE SYRINGE TO THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE TUBING SET. ATG THIS TIME, THE SEMI-RIGID ADAPTER ON THE CLAVE SECONDARY PORT BENT FORWARD AND SNAPPED OFF.. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108940 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA 350155H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA 10ML PREFILLED SALINE SYRINGE, LIST # UNK,| LOT # UNK, MFR UNK