BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CONTINUOUS NERVE BLOCK KIT

    MDR report key: 4152522 · Received October 6, 2014

    Report

    Report Number
    1036844-2014-00404
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    OGJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE STIMUCATH WITH NO RELEVANT FINDINGS. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFO PROVIDED AND WITHOUT A SAMPLE. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED BECAUSE NO SAMPLE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS FOR THE STIMUCATH WERE REVIEWED WITH NO EVIDENCE OF SUGGEST A MFG RELATED CAUSE. THE POTENTIAL CAUSE OF A CATHETER LEAK COULD NOT BE DETERMINED BASED ON THE INFO PROVIDED AND WITHOUT A SAMPLE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE CATHETER HAD A PIN HOLE SIZE LEAK LOCATED OUTSIDE OF THE PATIENT'S BODY. THE CATHETER WAS REMOVED AND THERE WAS NO PATIENT INJURY OR CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622124 ARROW CONTINUOUS NERVE BLOCK KIT ANESTHESIA CONDUCTION KIT OGJ ARROW INTL., INC. 23F14C0764

    Patients

    Seq Age Sex Outcome Treatment
    1