BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROPICC

    MDR report key: 10145394 · Received June 11, 2020

    Report

    Report Number
    3015060232-2020-00003
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    May 16, 2020
    Report Date
    June 11, 2020
    Manufacturer
    ACCESS VASCULAR, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICIAN REPORTED THAT ON (B)(6) 2020, THE HYDROPICC WAS REMOVED, AND "PT UNDERWENT A SUCCESSFUL REWIRE FOR A NEW 4FR SL POWER PICC(41CM)", AND WAS SUBSEQUENTLY DISCHARED HOME.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THAT THE "PATIENT WAS ADMITTED TO THE HOSPITAL WITH ALTERED MENTAL STATUS AND FOUND TO HAVE ACUTE TOXIC METABOLIC ENCEPHALOPATHY DUE TO SEVERE SEPSIS SECONDARY TO GROUP B STREP BACTEREMIA". ON THE SAME DATE, THE PATIENT MADE A VISIT TO THE IR SUITE TO HAVE THE PICC EVALUATED, WHERE IT WAS NOTED THAT "ON INITIAL ASSESSMENT, PATIENT ALERT AND APPEARS IN NO DISTRESS, LYING IN HER BED. THE PICC INSERTION SITE W/O S/SX OF INFECTION, WETNESS NOTED UNDER THE DRESSING BUT THE DRESSING BOARDER IS INTACT. BLOOD NOTED IN PICC LINE NEAR INSERTION SITE." IT WAS FURTHER REPORTED THAT "... AFTER DRESSING CHANGED SL PICC LINE FLUSHED WITH NS AND IMMEDIATELY NOTED SALINE LEAKING AT INSERTION SITE UNDER THE DRESSING FOLLOWED BY PINK TINGED FLUID LEAKING FROM THE INSERTION SITE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607623 HYDROPICC PERIPHERALLY INSERTED CENTRAL CATHETER LJS ACCESS VASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other CEFTRIAXONE 2G Q24 HOURS