BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 FR DL PER-Q-CATH PLUS MIDLINE SAFETY INTERMEDIATE TRAY

    MDR report key: 1930012 · Received November 19, 2010

    Report

    Report Number
    3006260740-2010-00349
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    August 14, 2010
    Report Date
    November 18, 2010
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K954422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVALUATION. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT.

    Description of Event or Problem · 1

    THE DEVICE CAME APART AT THE HUB. THE CATHETER WAS STILL IN THE SITE AND REMOVED INTACT. THE PT WAS WALKING WITH THE PHYSICAL THERAPIST, ONCE BACK TO THE ROOM, THE CATHETER SEPARATED FROM THE HUB. SHE IS NOT SURE IF AN IV WAS CONNECTED DURING THE WALK, SHE DOES FEEL THAT THE ITEM NEEDS SOME TYPE OF SECUREMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR DL PER-Q-CATH PLUS MIDLINE SAFETY INTERMEDIATE TRAY LJS C.R. BARD, INC. (BASD) REUB0794

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention