BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSLF EXT SET W CLV

    MDR report key: 3061616 · Received April 11, 2013

    Report

    Report Number
    9613251-2013-00106
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 27, 2013
    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

    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 LEAKS. ON UNSPECIFIED DATES, THE MALE ADAPTER OF POWER INJECTOR TUBING SETS WERE CONNECTED TO THE CLAVE PORT OF THE EXTENSION TUBING SETS AND WERE BEING USED TO DELIVER 100ML OF UNSPECIFIED CONTRAST MEDIUMS, AT A RATE OF 3ML/SEC, WITH A PRESSURE SETTING LESS THAN 325PSI VIA POWER INJECTORS. THE OPTION-LOK MALE ADAPTER OF THE EXTENSION TUBING SETS WERE CONNECTED TO THE PATIENT'S IV ACCESS SITES. THE CUSTOMER CONTACT REPORTED THAT LESS THAN 5 MINUTES AFTER THE DELIVERIES WERE STARTED, 10-15ML OF CONTRAST MEDIUM LEAKED FROM THE CONNECTION OF THE CLAVE PORT AND THE SEMI-RIGID FEMALE ADAPTER OF THE EXTENSION TUBING SETS. THE EXTENSION TUBING SETS WERE REPLACED AND PROCEDURES WERE RESUMED. THERE WERE NO REPORTS OF 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155498 LSLF EXT SET W CLV 80FPA FPA HOSPIRA LTD. NA UNKNS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED CONTRAST MEDIUM: MFR UNK| UNSPECIFIED POWER INJECTOR: MFR MEDRAD, INC.