BEUDAMED
    FDA Adverse Event Summary report: N

    PERIFIX

    MDR report key: 2132510 · Received June 6, 2011

    Report

    Report Number
    2132510
    Date Received
    June 6, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 6, 2011
    Manufacturer
    B. BRAUN MEDICAL ,INC.
    Product Code
    CAZ
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    STAFF NOTICED THE BLUE TIP ON THE END OF 3 CATHETER KITS WERE MUCH SHORTER THAN USUAL. THE PHYSICIAN FELT THAT IF A NURSE REMOVED ONE OF THE CATHETERS, HE/SHE MAY BELIEVE THAT THE TIP HAD BROKEN OFF. ALL 3 CATHETER KITS WERE FROM THE SAME LOT.======================MANUFACTURER RESPONSE FOR CONTINUOUS EPIDURAL TRAYS, PERIFIX (PER SITE REPORTER)======================SENDING OUT A REP REPRESENTATIVE TO VIEW THE PRODUCT AND DETERMINE IF THIS IS A DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIFIX CONTINUOUS EPIDURAL TRAYS CAZ B. BRAUN MEDICAL ,INC. * 61132024

    Patients

    Seq Age Sex Outcome Treatment
    1 *