BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW CENTRAL VENOUS CATHETER

    MDR report key: 15310902 · Received August 26, 2022

    Report

    Report Number
    MW5111742
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    July 21, 2022
    Report Date
    July 25, 2022
    Manufacturer
    ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
    Product Code
    FOZ
    UDI-DI
    20801902117223
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE PLACING A RIGHT FEMORAL MML, DR. (B)(6) WAS REMOVING THE GUIDEWIRE, DR. (B)(6) STATED THAT SHE FELT THAT THE LINE ¿BROKE¿. SHE REMOVED THE MML, AND GUIDEWIRE AND IT WAS DISCOVERED THAT THE GUIDEWIRE WAS FRAYED AND PARTIALLY CAME APART, POTENTIALLY BECOMING CATASTROPHIC TO THE PATIENT. DR. (B)(6) DECIDED TO DISCONTINUE THE LINE INSERTION. DR. (B)(6) HELD PRESSURE OVER THE INSERTION SITE TO STOP THE BLEEDING. DR. (B)(6) THEN DECIDED TO PLACE A DIFFERENT MML AT A DIFFERENT SITE. THE GUIDEWIRE AND PACKAGING FOR THE MML WAS SAVED FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147313 ARROW CENTRAL VENOUS CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) IPN036482 13F22A0732 20801902117223

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention