BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERGLIDE MEDLINE CATHETER, 20G 8CM

    MDR report key: 4193242 · Received October 17, 2014

    Report

    Report Number
    3006260740-2014-00526
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 10, 2014
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K121073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW (LHR) OF REYC1004 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THESE LOT NUMBERS. THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION, AS THE DEVICE IS BEING RETAINED BY THE REPORTING FACILITY.

    Description of Event or Problem · 1

    ON (B)(6) 2014 - UNABLE TO ESTABLISH VENOUS ACCESS. UNABLE TO ADVANCE CATHETER. WITHDRAWAL ATTEMPT MEET WITH SOME RESISTANCE. WITHDRAWAL ATTEMPT STOPPED FOR PERIOD OF 2 TO 3 MINUTES. WITHDRAWAL ATTEMPT OF DEVICE INITIATED AT MOMENT OF ATTEMPT START NOTED FLEXIBLE GUIDE WIRE BEGINNING TO EMERGE FROM SKIN SURFACE THEN FLEXIBLE WIRE DETACHED FROM NONFLEXIBLE PORTION OF DEVICE. TOURNIQUET KEPT IN PLACE AND NURSING AND MEDICAL STAFF NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662856 POWERGLIDE MEDLINE CATHETER, 20G 8CM FOZ BARD ACCESS SYSTEMS INC. REYC1004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention