BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE MODULE ADMINISTRATION SET

    MDR report key: 2101952 · Received May 18, 2011

    Report

    Report Number
    9616066-2011-00243
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K0811885
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 05/18/2011. (B)(4). PRODUCT EVALUATED AND CUSTOMER'S EXPERIENCE OF A LEAK FROM THE FEMALE LUER WAS CONFIRMED. THE FEMALE LUER HAD A 0.559IN 'L' SHAPED CRACK ON IT. THE ROOT CAUSE OF THE CRACK COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CLINICIAN REPORTED A CRACKED FEMALE LUER THAT CAUSED LEAKING ON THE FLOOR AND BLOOD BACKED UP TO THE FILTER. SHE OBSERVED THE VERTICAL CRACK WERE THE 10ML BD SYRINGE LOCKS ONTO THE LUER. VANCOMYCIN WAS INFUSING. THE SET WAS NEW AND HAD BEEN USED FOR 30 MINS TO 1 HOUR. NO PT HARM REPORTED. NO ADDITIONAL PT OR EVENT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYRINGE MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 10014916 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR ALARIS SYRINGE: MODEL, SERIAL NUMBER UNK| ALARIS PC UNIT: SERIAL NUMBER UNK