BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAINAGE SET

    MDR report key: 1616324 · Received February 24, 2010

    Report

    Report Number
    1036844-2010-00052
    Event Type
    Malfunction
    Date Received
    February 24, 2010
    Date of Event
    August 1, 2009
    Report Date
    February 24, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    GBX
    PMA / PMN Number
    K895516
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INSERTION PROCEDURE, THE EXTENSION LINE (INFUSION LINE) BROKE OFF AT THE HUB. THE SISTER WHO ASSISTED THE CLINICIAN DOES NOT WORK IN THE INTENSIVE CARE UNIT ANYMORE AND HAS BEEN UNABLE TO BE CONTACTED FOR MORE DETAILS AS TO WHAT HAPPENED. THERE WERE NO REPORTED PT COMPLICATIONS. ADDITIONAL INFO AVAILABLE CONCERNING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAINAGE SET CAVITY DRAINAGE CATHETER PRODUCTS GBX ARROW INTL., INC. RF9016814

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK