BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3770085 · Received January 28, 2014

    Report

    Report Number
    9615050-2014-00723
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    January 1, 2013
    Report Date
    January 2, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICES WERE DISCARDED. INVESTIGATION IS NOT COMPLETE. 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 DEVICE BREAKAGE; SUBSEQUENTLY, LEAKS WERE NOTED. ON UNSPECIFIED DATES, THE PRIMARY TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS, AT AN UNSPECIFIED RATE. AFTER UNSPECIFIED LENGTHS OF TIME, IT WAS REPORTED THAT THE MALE ADAPTER OF SECONDARY TUBING SETS WERE CONNECTED TO THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE TUBING SETS FOR PIGGYBACK DELIVERIES OF UNSPECIFIED SOLUTIONS. AFTER UNSPECIFIED LENGTHS OF TIME AFTER THE PIGGYBACK DELIVERIES WERE STARTED, THE CUSTOMER CONTACT REPORTED THAT THE SEMI-RIGID ADAPTER OF THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE TUBING SETS BROKE OFF AND UNSPECIFIED VOLUMES OF SOLUTION LEAKED. NO SPECIFIC DETAILS WERE PROVIDED. THE CUSTOMER CONTACT INDICATED THAT THE SEMI-RIGID ADAPTERS WERE FLIMSY AND BENT EASILY. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS OF THERAPIES CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61082 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SECONDARY TUBING SETS, LIST #UNK, LOT #UNK