BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPTYCONTAINER

    MDR report key: 2855553 · Received November 21, 2012

    Report

    Report Number
    MW5027820
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BAXA CORPORATION
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    FOUND SLIVER OF WOOD WHEN WITHDRAWING SOLUTION FROM HOSPIRA 500ML EMPTY CONTAINER AFTER FILLING WITH BAXTER NS 0.9% USING A BAXA REPEATER PUMP AND ADDING PFIZERPEN G (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPTYCONTAINER KPE BAXA CORPORATION 19 044 4W
    2 SODIUM CHLORIDE INJECTION KPE BAXA CORPORATION C846394
    3 SODIUM CHLORIDE INJECTION KPE BAXA CORPORATION C878272
    4 BAXA REPEATER PUMP TUBING FLUID TRANSFER TUBE SET FPA BAXA CORPORATION 775429

    Patients

    Seq Age Sex Outcome Treatment
    1 SODIUM CHLORIDE 0.9% 1000ML C878272, EXP: 02/2014| PFIZERPEN G 20MU: LOT #38301302, EXP: 06/2015| HOSPIRA EMPTY CONTAINER 500ML: LOT # 19 044 4W| SODIUM CHLORIDE 0.9% 1000ML C882225, EXP: 03/2014| SODIUM CHLORIDE 0.9% 1000ML C846394, EXP: 02/2013