BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKIT PLUS EPIDURAL CATHETER SECUREMENT DEVICE

    MDR report key: 3170435 · Received June 10, 2013

    Report

    Report Number
    2183502-2013-00308
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    April 28, 2013
    Report Date
    June 7, 2013
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    BSO
    PMA / PMN Number
    K051524
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE REPORTED DEVICE WAS IN USE WITH PATIENT ALONG WITH EPIDURAL CATHETER FOR ANESTHESIA DURING CHILDBIRTH. ACCORDING TO REPORTER AFTER BIRTH THE CATHETER AND LOCKIT PLUS WERE REMOVED FROM USE AND THE DISTAL PORTION OF THE EPIDURAL CATHETER WAS FOUND MISSING AT THE POINT WHERE THE CATHETER COINCIDED WITH THE LOCKIT PLUS DEVICE. THE CATHETER PORTION WAS RETRIEVED AT APPROX 1 CM BELOW THE SURFACE OF THE SKIN. NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261495 LOCKIT PLUS EPIDURAL CATHETER SECUREMENT DEVICE ANAESTHESIA CONDUCTION CATHETER SECUREMENT DEVICE BSO SMITHS MEDICAL MD, INC. NA 2319161

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention