BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER PICC

    MDR report key: 5774810 · Received July 1, 2016

    Report

    Report Number
    MW5063248
    Event Type
    Injury
    Date Received
    July 1, 2016
    Date of Event
    June 28, 2016
    Report Date
    July 1, 2016
    Manufacturer
    BARD ACCESS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BARD POWER PICC 55 CM 5 FRENCH LOT NUMBER REAQ2482 PLACED VIA RIGHT CEPHALIC, PICC TRIMMED 10 CM AND POSITIONED AT 42 CM MARK. CXR ON (B)(6) 2016 SHOWED APPROPRIATE POSITION FOR PICC TIP. THIN METALLIC OBJECT APPROX 3 CM AT LEVEL OF RIGHT AXILLARY VEIN WAS NOTED BY RADIOLOGY ON (B)(6) 2016. INTERVENTIONAL RADIOLOGY CONSULTED AND RETRIEVED FOREIGN OBJECT UNDER FLUOROSCOPY. PICTURE TAKEN OF OBJECT BY RADIOLOGIST CONSISTENT WITH TIP OF STYLET USED WITH POWER PICC. FBO WAS NOT KEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419396 POWER PICC POWER PICC LJS BARD ACCESS 3175355 REAQ2482

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention