BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOGLIDE KIT

    MDR report key: 1132436 · Received August 22, 2008

    Report

    Report Number
    3006260740-2008-00083
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    June 4, 2008
    Report Date
    August 1, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K010567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVALUATION. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT ARRIVED AT THE HOSPITAL FOR DIALYSIS WITH THE ARTERIAL EXT. TUBING FILLED WITH BLOOD. BEFORE STARTING THE DIALYSIS, A LEAK COULD BE SEEN JUST PROXIMAL TO THE BIFURCATION OF THE ARTERIAL LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOGLIDE KIT MSD C. R. BARD INC. (BASD) RERI0616

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention