BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERGLIDE MIDLINE CATHETER FULL KIT (20G) (10CM)

    MDR report key: 3934622 · Received June 26, 2014

    Report

    Report Number
    3006260740-2014-00324
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K121073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL, AS THE DEVICE IS BEING RETAINED BY THE REPORTING FACILITY. A LOT HISTORY REVIEW (LHR) OF REYB1766 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    DURING INSERTION OF MIDLINE CATHETER RESISTANCE WAS MET DURING PROCEDURE. ATTEMPTS WERE MADE TO SAFELY ADVANCE AND REMOVE THE CATHETER. THE NEEDLE AND GUIDEWIRE AND A PORTION OF THE CATHETER WERE REMOVED. IT WAS NOTED THAT A PORTION OF THE CATHETER WAS SHEARED OFF UNDER THE SKIN. THIS REQUIRED SURGICAL INTERVENTION TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373161 POWERGLIDE MIDLINE CATHETER FULL KIT (20G) (10CM) FOZ BARD ACCESS SYSTEMS INC. REYB1766

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention