BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASEAL PROTECTOR 21

    MDR report key: 2004634 · Received February 25, 2011

    Report

    Report Number
    MW5019584
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CHEMO THERAPY PREPARATION WITH GEMCITABINE (GEMZAR) 1GRM USED LOT A813733A EXP 11/2013. PREP USING PHASEAL PROTECTOR 21, LOT 10091105, EXP 2015/09. NEEDLE ON PHASEAL CAP CAME OFF AND LEFT STUCK IN VIAL STOPPER. CHEMO EXPOSURE RESULTED. CHEMOTHERAPY PREPARATION WITH FLUOROURACIL 50 MG/ML 100ML VIAL FROM (B)(4), LOT 6101200, EXP 06/2012. PREPARED USING PHASEAL P5O PROTECTOR LOT 10090841 EXP 2015/09. DURING PREPARATION, THE PLASTIC CONNECTOR ON THE PHASEAL TOP THAT ATTACHES TO THE SYRINGE BROKE OFF CAUSING A CHEMOTHERAPY SPILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHASEAL PROTECTOR 21 NONE FPA P21 10091105
    2 PHASEAL PROTECTOR 50 NONE FPA P50 10090841

    Patients

    Seq Age Sex Outcome Treatment
    1