BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW ENDURANCE CATHETER

    MDR report key: 8194434 · Received December 21, 2018

    Report

    Report Number
    MW5082553
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    December 13, 2018
    Report Date
    December 20, 2018
    Manufacturer
    TELEFLEX, INC. / ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    UDI-DI
    10801902132922
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PERIPHERAL IV PLACED VIA ULTRASOUND USING A TECHNIQUE CALLED ACCELERATED SELDINGER(AST). THE NURSE RETRACTED THE DEVICE BY GRASPING THE CATHETER PULLING IT BACK OVER THE NEEDLE APPROXIMATELY 0.5 CM. ON INSPECTION OF THE DEVICE 0.5 CM WAS MISSING FROM THE END OF THE CATHETER. UNABLE TO VISUALLY DETERMINE IF IT FELL ON THE BED ON REMOVAL, THE RN RESPONDED IMMEDIATELY NOTIFYING THE NURSE MANAGER FOR DIRECTION. THEY PHYSICIAN WAS NOTIFIED AND X-RAYS WERE ORDERED AS RECOMMENDED. THE MEDICAL DIRECTOR WAS NOTIFIED AND COLLABORATED WITH THE CARE AND TREATMENT RECOMMENDATIONS. THE FOREIGN BODY WAS IDENTIFIED IN THE SOFT TISSUE VS THE VESSEL, VIA X-RAY OF ARM. CHEST X-RAY WAS NEGATIVE FOR FOREIGN BODY. A CT SCAN WAS DONE TO FURTHER DEFINE THE LOCATION OF THE CATHETER TIP. THE PATIENT WAS MADE NPO FOR LOCAL ANESTHETIC REMOVAL IN OPERATING ROOM . PATIENT TOLERATED THE REMOVAL PROCEDURE AND WAS DISCHARGED TO HOME IN STABLE CONDITION THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027711 ARROW ENDURANCE CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM LESS THAN 30 DAYS FOZ TELEFLEX, INC. / ARROW INTERNATIONAL INC. IPN037860 14F18H0262 10801902132922

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R