BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS EXTENSION SET

    MDR report key: 3043486 · Received March 13, 2013

    Report

    Report Number
    9616066-2013-00160
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 18, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER AS SET WAS DISCARDED. THE CUSTOMER COMPLAINT OF FEMALE LUER CRACKED AND LEAKED COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS IDENTIFIED.

    Description of Event or Problem · 1

    HOSPITAL REPORTED THE FEMALE LUER CRACKED. THEY ATTACHED A SYRINGE TO THE FEMALE LUER AND HAND INJECTED CONTRAST. THE FEMALE LUER CRACKED AND CONTRAST SQUIRTED OUT. THERE WAS NO PT OR USER HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO FURTHER PT/EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106484 ALARIS EXTENSION SET FPA CAREFUSION CORPORATION C20016 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SYRINGE: MFR/MODEL/LOT UNK