BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLONG

    MDR report key: 1950979 · Received January 5, 2011

    Report

    Report Number
    1625424-2010-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    November 16, 2010
    Report Date
    December 15, 2010
    Manufacturer
    LIFE-TECH, INC.
    Product Code
    BSP
    PMA / PMN Number
    K081864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS REPORTED TO US BY SMITHS MEDICAL, WHOSE NAME APPEARS ON ALL LABELING, FOR WHOM WE PRIVATE-LABEL THIS PRODUCT. EFFORTS TO RETRIEVE PT IDENTIFICATION INFO FROM SMITHS HAS BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    INSERTION OF THE NEEDLE PRESENTED NO PROBLEM. DURING INTRODUCTION OF THE CATHETER THROUGH THE NEEDLE, THERE WAS RESISTANCE AFTER 4CM. AFTER DRAWING AND REINSERTING THE CATHETER, THERE WAS THE SAME PROBLEM. DURING REMOVAL OF THE NEEDLE, THE NEEDLE DETACHED FROM THE LUER AND REMAINED IN THE PT. THE NEEDLE HAD TO BE REMOVED FROM THE GROIN OF THE PT BY SURGERY. LIFE-TECH WAS INFORMED OF THIS EVENT ON NOVEMBER 24 BY OUR OEM PARTNER, FOR WHOM THIS PRODUCT IS PRIVATE-LABELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLONG ANESTHESIA CONDUCTION NEEDLE BSP LIFE-TECH, INC. 19/050/PL 2K01101

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention