BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWER PORT

    MDR report key: 3731815 · Received April 2, 2014

    Report

    Report Number
    MW5035476
    Event Type
    Other
    Date Received
    April 2, 2014
    Date of Event
    February 21, 2014
    Report Date
    April 1, 2014
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    LJT
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SITUATION: RETAINED PORTION OF A POWER PORT STYLET WIRE DETECTED AND REMOVED. BACKGROUND: ON (B)(6) 2013 A POWER PORT REF: (B)(4) LOT: REXF0609 WAS INSERTED FOR ANGIOACCESS IN THE OPERATING ROOM AS AN OUTPATIENT. THE PT HAD BEEN RECEIVING CHEMOTHERAPY TREATMENTS VIA THE PORT WITHOUT DIFFICULTIES. ON (B)(6) 2014 AN ECHOCARDIOGRAM DETECTED A WIRE FRAGMENT IN THE RIGHT ATRIUM AND INFERIOR VENA CAVA. THIS WAS CONFIRMED ON CHEST X-RAY. THE PT THEN WENT TO INTERVENTIONAL RADIOLOGY AND A STYLET WIRE 15 CM IN LENGTH WAS REMOVED FROM THE INFERIOR VENA CAVA. A LEFT CHEST PORT-A-CATH STUDY SHOWED EXTRAVASATION AT THE CATHETER/PORT JUNCTION. THE PORT-A-CATH WAS REMOVED AND A NEW PORT-A-CATH WAS INSERTED. THE PT WAS RELEASED TO HOME THE SAME AFTERNOON, (B)(6) 2014. ASSESSMENT: UNINTENDED RETENTION OF A FOREIGN OBJECT (URFO) REQUEST: REQUEST TO MANUFACTURER. PLEASE CONSIDER A PRODUCT ENHANCEMENT OF COLORING THE TIP OF THE STYLET WIRE. THE ADDITION OF A VISUAL CUE FOR THE PROCEDURALIST THAT ALL OF THE WIRE HAS BEEN REMOVED WILL IMPROVE PT SAFETY AND REDUCE UNINTENDED RETAINED FOREIGN OBJECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199871 POWER PORT POWER PORT LJT BARD MEDICAL DIVISION REXF0609

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other