BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60" EXT W/M/FLL CLAMP

    MDR report key: 1032213 · Received April 18, 2008

    Report

    Report Number
    1526863-2008-00015
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    February 16, 2008
    Report Date
    March 25, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    PMA / PMN Number
    K831087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES HAVE BEEN RECEIVED FROM THE CUSTOMER; HOWEVER, SMITHS HAS NOT YET COMPLETED ITS INVESTIGATION INTO THIS MATTER. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT ON TWO OCCASIONS, THE TUBING FELL APART. BOTH WERE FROM THE SAME LOT. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 60" EXT W/M/FLL CLAMP EXTENSION SET FPA SMITHS MEDICAL ASD, INC. NA 37H20D030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK