BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC SOLO

    MDR report key: 11378042 · Received February 24, 2021

    Report

    Report Number
    MW5099623
    Event Type
    Injury
    Date Received
    February 24, 2021
    Date of Event
    August 9, 2020
    Report Date
    February 22, 2021
    Manufacturer
    C.R. BARD, INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MANY EPISODES OF DEBILITATING BONE PAIN, FEVER, RIGORS, ETC. MANY DRS, LAB TESTS, CULTURES, ER VISITS OVER 5 MONTHS. TURNED OUT TO BE TWO BACTERIA IN PICC LINE AND I WAS FLUSHING IT INTO MY BLOODSTREAM EVERY DAY FOR FIVE MONTHS. PICC REMOVED. TOO MANY TESTS TO LIST BELOW. SECOND BACTERIA FOUND PANTOEA SPECIES. NEITHER OF THESE BACTERIA WERE FOUND IN BLOOD CULTURES DRAWN FROM THE OPPOSITE ARM OVER THE COURSE OF FIVE MONTHS. ONLY ONCE THE CATHETER WAS REMOVED AND CULTURED DID THESE BACTERIA FINALLY GET PICKED UP. PATIENT (MYSELF) SUFFERED DEBILITATING "MYSTERY ILLNESS" FOR FIVE MONTHS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273037 POWERPICC SOLO CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R