BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSH 3FRSL PICC BASIC & 5.5FR MICROINTRO

    MDR report key: 3851830 · Received April 11, 2014

    Report

    Report Number
    3006260740-2014-00178
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 21, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K926331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION.

    Description of Event or Problem · 1

    PICC WAS INSERTED INTO A CHILD WITH DIFFICULT VEIN ACCESS. HOWEVER UNFORTUNATELY THE GROSHONG CATHETER WAS FOUND TO BE BROKEN AT THE HUB (SEE ACTUAL COMPLAINT PRODUCT). NO ONE WAS ABLE TO ADVISE WHAT HAPPEN. APPARENTLY CATHETER WAS OKAY INITIALLY BUT FOUND BROKEN THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221361 GROSH 3FRSL PICC BASIC & 5.5FR MICROINTRO LJS C.R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention