BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD POWER PICC SOLO

    MDR report key: 1862207 · Received October 7, 2010

    Report

    Report Number
    1862207
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 22, 2010
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEFT BASILIC ACCESSED WITH 51G NEEDLE UNDER ULTRASOUND (B)(4) , MICROINTRODUCER AND CATHETER ADVANCED EASILY. (B)(4) GUIDEWIRE REMOVED FROM CATHETER, (B)(4) RECALIBRATED. (B)(4) GUIDEWIRE REINTRODUCED TO CATHETER THEN REMOVED. NURSE LOOKED DOWN AT THE (B)(4) GUIDEWIRE BEFORE NURSE WENT TO REINTRODUCE THE WIRE FOR THE SECOND TIME AND NOTICED THE END WAS BENT AND BARELEY HANGING ON. (B)(4) GUIDEWIRE WAS THEN PLACED TO THE SIDE AND NOT USED ANY FURTHER. PICC LINE WAS SECURED AND DRESSED STAT PCXR WAS OBTAINED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD POWER PICC SOLO PICC LINE LJS REUF0885

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR