BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CONTINUOUS PERIPHERAL NERVE BLOCK KIT; 2

    MDR report key: 4999153 · Received August 11, 2015

    Report

    Report Number
    1036844-2015-00321
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ARROW INTL., INC.
    Product Code
    OGJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON A LOT NUMBER FROM SALES HISTORY. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE CATHETER AND NEEDLE WITH NO RELEVANT FINDINGS. THE IFU FOR THIS PRODUCT WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU FOR THIS PRODUCT STATES "USE EXTREME CARE TO NEVER ADJUST POSITION OF THE NEEDLE WHILE CATHETER TIP IS STILL ADVANCED BEYOND TIP OF NEEDLE." IF THE CATHETER IS RETRACTED AGAINST THE NEEDLE BEVEL, IT CAN LEAD THE CATHETER TO SHEAR AS THE CUSTOMER REPORTED. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE POTENTIAL CAUSE OF DIFFICULTY THREADING THE CATHETER COULD NOT BE DETERMINED BASED UPON THE INFO PROVIDED AND WITHOUT THE SAMPLE. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE POTENTIAL CAUSE OF DIFFICULTY THREADING THE CATHETER THROUGH THE NEEDLE COULD NOT BE DETERMINED BASED UPON THE INFO PROVIDED AND WITHOUT A SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER ALLEGES HAVING DIFFICULTY IN REMOVING THE NEEDLE AND STYLET. THE CATHETER SHEARED AND HAD TO BE RESTARTED. NO PT INJURY REPORTED. PROCEDURE - TOTAL KNEE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526401 ARROW CONTINUOUS PERIPHERAL NERVE BLOCK KIT; 2 ANESTHESIA CONDUCTION KIT OGJ ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1