BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORMAL SALINE IV FLUSH

    MDR report key: 996464 · Received February 3, 2008

    Report

    Report Number
    MW5005333
    Event Type
    Injury
    Date Received
    February 3, 2008
    Date of Event
    December 31, 2007
    Report Date
    February 3, 2008
    Manufacturer
    BRAUN
    Product Code
    NGT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS HOSPITALIZED WITH COMPLICATIONS FROM A LUMPECTOMY. I WAS PUT ON ZOSYN IV THERAPY IN 2008. I ALSO HAD MY INCISION REOPENED AND LEFT OPEN TO HEAL FROM THE INSIDE OUT. SINCE THEN, I CAME HOME ON IV ZOSYN FIVE DAYS LATER, AND I AM STILL ON IT. MY OPEN INCISION IS FLUSHED OUT WITH TWO NORMAL SALINE FLUSH 10ML DAILY AND I HAVE A PICC LINE IN MY ARM, THAT IS FLUSHED 6 SIX TIMES DAILY, ALSO WITH THE SAME SOLUTIONS. NDIC # 64054-0910-2 CATALOG # 0910-12 PRODUCT NAME: NORMAL SALINE FLUSH 10ML. IN THIS BATCH LOT, I HAVE USED 45 SYRINGES. I HAVE BEEN EXPERIENCING MUSCLE ACHES, COLD CHILLS, NAUSEA, HEADACHE, FLU LIKE SYMPTOMS, BURNING IN MY KNEES GOING DOWN TO MY FEET. I FOUND OUT A COUPLE OF DAYS AGO THAT THERE WAS A RECALL ON THIS BATCH LOT. I DON'T KNOW IF PREVIOUS BATCH LOT WERE ALSO CONTAMINATED. DOSE OR AMOUNT: PRE-FILLED USED ON IV; FREQUENCY: 6 SIX TIMES DAILY; ROUTE: IV. DOSE OR AMOUNT: PRE-FILLED OPEN INCISION SIGHT; FREQUENCY: TWO TIMES DAILY. DATES OF USE: PRESENT FIFTEEN DAYS IN 2008. DIAGNOSIS OR REASON FOR USE: INFECTION FROM A LUMPECTOMY, HOME IV THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORMAL SALINE IV FLUSH 10ML NGT BRAUN 070917A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization