BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANCOMYCIN ADD-VANTAGE 750 MG

    MDR report key: 2883921 · Received December 3, 2012

    Report

    Report Number
    MW5028246
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 3, 2012
    Manufacturer
    HOSPIRA
    Product Code
    KYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    VANCOMYCIN 750 MG ADD-VANTAGE SCREWED WITH NS 250 ML ADD-VANTAGE BAG BY PHARMACY AND SENT TO PT CARE UNIT. WHEN READY TO ADMINISTER, NURSE 'ACTIVATED' THE BAG BY REMOVING THE INTERNAL PLUNGER TO ADMIX THE SALINE WITH THE ANTIBIOTIC POWDER. AFTER MIXING THE COMPONENTS, SHE NOTICED THAT THE ADMIXTURE WAS LEAKING. UPON FURTHER INVESTIGATION, THE ADD-VANTAGE ADMIXTURE WAS LEAKING FROM THE TOP OF THE VIAL WHERE YOU WOULD PULL UP A TAB FOR HANGING ON THE IV POLE. IT WAS NOT LEAKING WHERE THE BAG/VIAL ARE SCREWED TOGETHER. THE LEAKING BAG WAS RETURNED TO PHARMACY DEPT AND A FRESH ADMIXTURE WAS PREPARED FOR THE PT. HOSPIRA CUSTOMER SERVICE WAS CONTACTED AT (B)(6) TO REPORT THE COMPLAINT. THEY ARE GOING TO SENT A RETURN FOR THE PRODUCT. REASON FOR USE: INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANCOMYCIN ADD-VANTAGE 750 MG VIAL KYX HOSPIRA 07155DD
    2 ADDVANTAGE BAG BAG KPE HOSPIRA 09-106-JT

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other