BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROTHERM EPIDURAL CATHETER

    MDR report key: 3162500 · Received June 6, 2013

    Report

    Report Number
    1226344-2013-00020
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 2, 2013
    Report Date
    June 5, 2013
    Manufacturer
    NEUROTHERM
    Product Code
    BSO
    PMA / PMN Number
    K050557
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY STATED THAT THEY HAVE SENT BACK THE REPORTED CATHETER ALONG WITH UNOPENED PRODUCTS. HOWEVER, NEUROTHERM HAS NOT RECEIVED THE CATHETER IN QUESTION AND THEREFORE, REQUESTED FOR THE SPECIFIC CATHETER TO BE RETURNED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, NEUROTHERM EMPLOYEE RECEIVED A CALL FROM THE FACILITY REPORTING THAT THE ENDS OF THE CATHETER ARE CURLING UP AND SHEARING OFF. NO PIECES WERE REPORTED TO BE LEFT BEHIND IN PATIENT. NO PATIENT INJURY WAS REPORTED. ON (B)(6) 2013, A NEUROTHERM EMPLOYEE CONFIRMED THAT THE FACILITY WAS USING A 17 GAUGE INTRODUCED WITH THE 19 GAUGE CATHETER. THE 16 GAUGE INTRODUCER SHOULD BE USED WITH THE 19 GAUGE CATHETER. THE 17 GAUGE INTRODUCER IS TOO SMALL WHICH CREATES FRICTION ON THE 19 GAUGE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250029 NEUROTHERM EPIDURAL CATHETER EPIDURAL CATHETER BSO NEUROTHERM NT-12-19 120331-1E

    Patients

    Seq Age Sex Outcome Treatment
    1 Other