BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 14 GA X 6" (16 CM)

    MDR report key: 5382946 · Received January 21, 2016

    Report

    Report Number
    3006425876-2016-00015
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Date of Event
    December 9, 2015
    Report Date
    January 11, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON EVALUATION OF A RETURNED PRODUCT SAMPLE. THE CUSTOMER PROVIDED A GUIDE WIRE WITH A SLIGHTLY OPENED J-TIP. THE GUIDE WIRE WAS INTACT AND WITHIN DIMENSIONAL SPECIFICATION. THE ADVANCER WAS ALSO RETURNED, BUT THE STRAIGHTENING TUBE AND END CAP WERE MISSING. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE GUIDE WIRE WAS FUNCTIONALLY TESTED WITH A LAB INVENTORY STRAIGHTENING TUBE AND WAS ABLE TO BE INSERTED AND ADVANCED WITHOUT ISSUE. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED WITH NO RELEVANT FINDINGS. THE IFU CONTAINS INSTRUCTIONS FOR INSERTING THE GUIDE WIRE INCLUDING TO USE YOUR THUMB, STRAIGHTEN THE "J" BY RETRACTING THE GUIDE WIRE INTO THE ADVANCER. WHEN THE TIP IS STRAIGHTENED, THE GUIDE WIRE IS READY FOR INSERTION. THE PROBABLE CAUSE OF THIS ISSUE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND WITHOUT A COMPLETE SAMPLE. NO FURTHER ACTION WILL BE TAKEN. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF THE CENTRAL VENOUS CATHETER, THE GUIDEWIRE GOT STUCK IN THE OPENING THAT LOCKS THE GUIDEWIRE HOLDER TO ITS DISTAL TIP; THIS CAUSED THE WIRE TO BEND. AS A RESULT, A NEW CATHETER HAD TO BE INSERTED USING A NEW KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41680 CVC SET: 14 GA X 6" (16 CM) SINGLE LUMEN CVC PRODUCTS DQY ARROW INTERNATIONAL INC. 71F15B1538

    Patients

    Seq Age Sex Outcome Treatment
    1