BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE-FREE SYRINGE WITH TEXIUM MALE LUER

    MDR report key: 3820765 · Received April 30, 2014

    Report

    Report Number
    9616066-2014-00419
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 10, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K071108
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: (B)(4) 2014. INTERNAL FILE NO: (B)(4). ALTHOUGH REQUESTED, THE SYRINGE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WITH INVESTIGATION RESULTS WILL BE SUBMITTED SHOULD THE SYRINGE BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CONNECTION DURING ADRIAMYCIN IV PUSH. THERE WAS A SMALL VOLUME DRIPPING AND THE NURSE CONTINUED THE IV PUSH WITH THE FLUID LEAKING ONTO PT'S BLANKET. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259597 NEEDLE-FREE SYRINGE WITH TEXIUM MALE LUER FPA CAREFUSION CORP MY8060 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE ADMIN SET:| MODEL 2420-0007/LOT UNK