BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER PORT

    MDR report key: 2021963 · Received March 7, 2011

    Report

    Report Number
    2021963
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 22, 2011
    Manufacturer
    C.R. BARD, INC
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS A (B)(6), FEMALE, BORN (B)(6). SHE WAS DIAGNOSED WITH ADENOCARCINOMA OF THE RIGHT BREAST. SHE HAD A POWER PORT PLACED IN THE LEFT SUBCLAVIAN VEIN IN (B)(6) 2008. THIS DEVICE WAS USED FOR CHEMOTHERAPY ADMINISTRATION, BUT HAD NOT BEEN USED FOR JUST OVER A YEAR. THE POWER PORT HAD ROUTINE FLUSHES EVERY SIX WEEKS. THE PATIENT ADVISED IT HAD NOT BEEN FLUSHING WELL OVER THE PAST 18 TO 20 WEEKS AND SHE WANTED THE DEVICE REMOVED. ON (B)(6) 2011, SURGERY WAS SCHEDULED TO REMOVE THE POWER PORT. THE PHYSICIAN, WHILE EXTRACTING THE HUB, NOTED THAT THE CATHETER WAS NO LONGER ATTACHED TO THE PORT. UPON INSPECTION OF THE HUB, THERE WAS A SMALL AMOUNT OF CATHETER ATTACHED TO IT. THE PATTERN OF THE FRACTURE WAS IRREGULAR. THE SECTION OF THE CATHETER THAT HAD FRACTURED COULD NOT BE FELT DURING THE PROCEDURE AND THE PHYSICIAN CHOSE TO ABORT ANY FURTHER ATTEMPT TO LOCATE THE REMAINING CATHETER. THE PATIENT WAS IMMEDIATELY SENT FOR A CHEST FILM WHICH SHOWED THAT THE CATHETER HAD MIGRATED SEVERAL CENTIMETERS. THE PATIENT WAS THEN TRANSFERRED TO INTERVENTIONAL RADIOLOGY WHERE THE CATHETER WAS SUCCESSFULLY RETRIEVED. THE PHYSICIAN BELIEVES THAT THE CATHETER HAD BECOME DETACHED PRIOR TO THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER PORT PORT-A-CATH LJT C.R. BARD, INC 1708001 RES80784

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention