BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25

    MDR report key: 8163067 · Received December 13, 2018

    Report

    Report Number
    3006260740-2018-03588
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 19, 2018
    Report Date
    December 13, 2018
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FOZ
    UDI-DI
    00801741110948
    PMA / PMN Number
    K153298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF RECT1726 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DISTAL PORTION OF GUIDEWIRE APPROXIMATELY 1CM IN LENGTH BROKE OFF AFTER FAILED INSERTION WHILE DOING AN U/S GUIDED IV USING BARD ACCUCATH IN PATIENTS RIGHT BICEP AREA. THE PORTION OF THE GUIDEWIRE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998753 ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BARD ACCESS SYSTEMS N/A RECT1726 00801741110948

    Patients

    Seq Age Sex Outcome Treatment
    1