BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 1033071 · Received April 22, 2008

    Report

    Report Number
    2523676-2008-00026
    Event Type
    Other
    Date Received
    April 22, 2008
    Report Date
    April 17, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICES IN THE INCIDENTS WERE DISCARDED AND NOT MADE AVAILABLE TO THE MANUFACTURER TO BE EVALUATED. WITHOUT THE SAMPLES, A THOROUGH EVALUATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY; TWO OR MORE INCIDENTS IN WHICH FILTER HAS CRACKED/SPLIT DURING ADMINISTRATION OF TAXOL, RESULTING IN LEAKAGE OF CHEMO DRUG. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED NO ONE SUFFERED ANY ADVERSE SEQUELA ASSOCIATED WITH THE REPORTED INCIDENTS. THE SAMPLES WERE DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. IT APPEARS THE INCIDENTS OCCUR MORE CONSISTENTLY WITH ONE NURSE. THE B.BRAUN SALES REP IS GOING TO BRING IN ALTERNATIVE PRODUCTS TO TRY THAT MAY BETTER SUIT THE FACILITY'S' APPLICATION. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA 0.2 MICRON FILTER ASSEMBLY FPB B. BRAUN MEDICAL, INC. PFE2000 60925586

    Patients

    Seq Age Sex Outcome Treatment
    1 Other