BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERIFIX

    MDR report key: 820685 · Received February 22, 2007

    Report

    Report Number
    2523676-2007-00002
    Event Type
    Other
    Date Received
    February 22, 2007
    Report Date
    February 2, 2007
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DRUG VIALS IN THE INCIDENTS WERE NOT RETURNED TO THE MANUFACTURE TO BE EVALUATED. WITHOUT THE SAMPLES A THOROUGH EVALUATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DRUG MANUFACTURER, HOSPIRA INC. FOR FURTHER INVESTIGATION. IF ANY INFORMATION IS RECEIVED FROM HOSPIRA INC. STATING THAT THERE IS AN INHERENT PROBLEM, THIS REPORT WILL RE-OPENED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: THREE INCIDENTS IN WHICH THEY HAD DIFFICULTY BREAKING OPEN THE AMPULES OF TEST DOSE LIDOCAINE - AMPULES DID NOT SEEM TO BE SCORED. IN ONE INCIDENT A CRNA CUT HIS HAND TRYING TO BREAK OPEN THE AMPULE. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THE CRNA IS FINE AND SUFFERED NO ADDITIONAL ADVERSE SEQUELA ASSOCIATED WITH THE INCIDENT. IT WAS REPORTED HE HAD A SLIGHT CUT ON HIS FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIFIX CONTINUOUS EPIDURAL TRAY CAZ B. BRAUN MEDICAL, INC. * 60883172

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other