BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 7 FR X 20 CM

    MDR report key: 10010181 · Received April 29, 2020

    Report

    Report Number
    3006425876-2020-00419
    Event Type
    Malfunction
    Date Received
    April 29, 2020
    Date of Event
    April 10, 2020
    Report Date
    April 29, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED MULTIPLE COMPONENTS FROM A CVC SET. THE INTRODUCER NEEDLE CANNULA WILL BE ANALYZED AS PART OF THIS COMPLAINT INVESTIGATION. THE INTRODUCER NEEDLE HUB WAS NOT RETURNED FOR ANALYSIS. VISUAL ANALYSIS REVEALED THAT THE CROSS SECTION OF THE BROKEN END OF THE CANNULA WAS OVAL SHAPED, WHICH INDICATES THAT THE CANNULA BECAME BENT THEN SEPARATED. MICROSCOPIC EXAMINATION CONFIRMED THE OVAL SHAPED POINT OF SEPARATION. VISUAL INSPECTION OF THE NEEDLE HUB COULD NOT BE COMPLETED SINCE THE HUB WAS NOT RETURNED. THE SEPARATED CANNULA MEASURED 2.875", WHICH INDICATES THAT AT LEAST .011" HAD SEPARATED AND WAS NOT RETURNED FOR ANALYSIS. THE INNER DIAMETER OF THE NEEDLE CANNULA MEASURED .041", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .041"-.043" PER THE CANNULA GRAPHIC. THE CANNULA OUTER DIAMETER MEASURED .0503", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .050"-.051" PER THE CANNULA GRAPHIC. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH NO RELEVANT FINDINGS. THE REPORTED COMPLAINT THAT THE INTRODUCER NEEDLE BROKE DURING INSERTION WAS CONFIRMED THROUGH VISUAL EXAMINATION OF THE RETURNED SAMPLE. THE CANNULA WAS SEPARATED JUST BELOW WHERE THE HUB SHOULD BE LOCATED. THE CANNULA MET ALL RELEVANT DIMENSIONAL SPECIFICATIONS, AND A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. BASED ON THE TIME OF DISCOVERY AND THE SAMPLE INVESTIGATION, UNINTENTIONAL USE ERROR LIKELY CONTRIBUTED TO THIS COMPLAINT, HOWEVER; THIS COULD NOT BE CONFIRMED AS THE NEEDLE HUB/OTHER END OF THE CANNULA WAS NOT RETURNED FOR EVALUATION. THEREFORE, A POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS: MD TRIED TO CONNECT THE NEEDLE TO THE SYRINGE TO INSERT THE CENTRAL VEIN, BUT THE END OF THE NEEDLE WAS BROKEN AND COULD NOT BE USED. THE MD OPENED A NEW KIT AND FINISHED THE PROCEDURE SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    (B)(4). PRELIMINARY EVALUATION OF THE RETURNED DEVICE INDICATES THE NEEDLE CANNULA BROKE DURING USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS: MD TRIED TO CONNECT THE NEEDLE TO THE SYRINGE TO INSERT THE CENTRAL VEIN, BUT THE END OF THE NEEDLE WAS BROKEN AND COULD NOT BE USED. THE MD OPENED A NEW KIT AND FINISHED THE PROCEDURE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472872 ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL INC. 71F18K0497

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNNOWN| UNKNNOWN| UNKNNOWN