BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDLYTE MICRO CAPILLARY TUBES

    MDR report key: 471686 · Received July 11, 2003

    Report

    Report Number
    1217157-2003-00001
    Event Type
    Other
    Date Received
    July 11, 2003
    Date of Event
    June 11, 2003
    Report Date
    July 11, 2003
    Manufacturer
    BAYER HEALTHCARE, SUBSIDURAY OF BAYER CORP.
    Product Code
    GIO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BAYER HEALTHCARE RECEIVED CUSTOMER COMPLAINT FOLLOWED BY CUSTOMER LETTER ABOUT FRAGILITY OF THE MICROCAPILLARY TUBES. IT WAS STATED BY THE CUSTOMER THAT USERS (NURSES) AT THEIR HOSPITAL FACILITY WERE INJURED BY BROKEN CAPILLARY TUBES WHILE CAPPING THE TUBES WHICH EXPOSED THEM TO PT BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDLYTE MICRO CAPILLARY TUBES LITHIUM HEPARINIZED MICRO CAPILLARY TUBES GIO BAYER HEALTHCARE, SUBSIDURAY OF BAYER CORP. NA 0606230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA