BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW FLEXBLOCK KIT: ECHO CATH, 17GX4CM, STM NDL

    MDR report key: 4188217 · Received October 16, 2014

    Report

    Report Number
    1036844-2014-00412
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 23, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    OGJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE STIMULATING NEEDLE AND FLEXBLOCK CATHETER WITH NO RELEVANT FINDINGS. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE DHR FOR THE STIMULATING NEEDLE AND FLEXBLOCK CATHETER WERE REVIEWED WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE POTENTIAL CAUSE OF A CATHETER NOT THREADING THROUGH THE NEEDLE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. IF THE SAMPLE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES THAT THE CATHETER WOULD NOT THREAD THROUGH THE NEEDLE. CATHETER APPEARED TO BE KINKED. THE ALLEGED DEFECT OCCURRED DURING USE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657027 ARROW FLEXBLOCK KIT: ECHO CATH, 17GX4CM, STM NDL ANESTHESIA CONDUCTION KIT OGJ ARROW INTL., INC. 23F14E1285

    Patients

    Seq Age Sex Outcome Treatment
    1