BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC KIT: 2-LUMEN 7FR X 20CM

    MDR report key: 7195676 · Received January 16, 2018

    Report

    Report Number
    3006425876-2018-00046
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    December 28, 2017
    Report Date
    January 4, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED A SINGLE INTRODUCER NEEDLE FOR EVALUATION. THE ARROW RAULERSON SYRINGE (ARS) WAS NOT RETURNED. VISUAL EXAMINATION OF THE NEEDLE HUB AND NEEDLE CANNULA DID NOT REVEAL ANY DEFECTS OR ANOMALIES. BASED ON THE ECHOGENIC STRIP ON THE NEEDLE CANNULA AND THE DIMENSIONAL INSPECTION, THE NEEDLE THAT WAS RETURNED IS PART# K-04300-033A. THE INTRODUCER NEEDLE INNER DIAMETER WAS MEASURED AND WAS WITHIN SPECIFICATION. THE RETURNED INTRODUCER NEEDLE WAS ATTACHED TO A TAPERED LAB INVENTORY ARS SYRINGE AND A THREADED LAB INVENTORY SYRINGE AND IT FIT SNUGGLY WITH BOTH SYRINGES WITH NO INDICATION THAT IT WAS LOOSE. WATER WAS ASPIRATED INTO THE SYRINGES AND NO LEAKS WERE PRESENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE INTRODUCER NEEDLES AND THE ARS AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE REPORT OF A LOOSE CONNECTION BETWEEN THE SYRINGE AND INTRODUCER NEEDLE COULD NOT BE CONFIRMED THROUGH EVALUATION OF THE RETURNED NEEDLE. THE NEEDLE LUER HUB PASSED VISUAL AND FUNCTIONAL TESTING. THE SYRINGE WAS NOT RETURNED BY THE CUSTOMER FOR EVALUATION. A POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED SINCE THE DEFECT COULD NOT BE REPRODUCED AND THE SYRINGE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE USER TRIED TO CONNECT INTRODUCER NEEDLE TO ARS SYRINGE, THE NEEDLE WAS NOT SECURE AND DETACHED FROM THE SYRINGE. AS A RESULT, ONLY THE NEEDLE WAS REPLACED BY ANOTHER ONE TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    QN#(B)(4). ADDITIONAL INFORMATION: THIS PRODUCT IS NOT SOLD IN THE US. THE 510K # PROVIDED IS FOR A SIMILAR PRODUCT THAT IS SOLD IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE USER TRIED TO CONNECT INTRODUCER NEEDLE TO ARS SYRINGE, THE NEEDLE WAS NOT SECURE AND DETACHED FROM THE SYRINGE. AS A RESULT, ONLY THE NEEDLE WAS REPLACED BY ANOTHER ONE TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37297 ARROW CVC KIT: 2-LUMEN 7FR X 20CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F17F1472

    Patients

    Seq Age Sex Outcome Treatment
    1