BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROPICC

    MDR report key: 10145379 · Received June 11, 2020

    Report

    Report Number
    3015060232-2020-00002
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    May 13, 2020
    Report Date
    June 11, 2020
    Manufacturer
    ACCESS VASCULAR, INC.
    Product Code
    LJS
    UDI-DI
    00862559000418
    PMA / PMN Number
    K193015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020, A FOLLOW-UP PHONE CONVERSATION WITH MR. (B)(6) DESCRIBED THE PATIENT CONDITIONS AS "HIGH BMI" AND "LARGE DEEP VEINS." IN ADDITION, THE CLINICIAN STATED THAT ON (B)(6) 2020 HE NOTED THAT THE CATHETER WAS "OUT 2 CM" (EXTENDING OUTSIDE THE PATIENT). THE CLINICIAN STATED THAT THEY CLEANED, RE-HYDRATED, AND RE-INSERTED THE CATHETER WITHOUT ISSUE; HOWEVER, ON (B)(6) 2020, THE HYDROPICC WAS LEAKING, AND WAS SUBSEQUENTLY REPLACED WITH A NON-HYDROPICC DEVICE. IT WAS MR. BUNCH'S OPINION THAT THE CAUSE OF THE KINK AND CRACK WAS DUE TO EITHER THE PATIENT SNAGGING THE DEVICE ON SOMETHING, OR DUE TO MANIPULATION OF THE DEVICE OR THE PATIENT, LIKELY DURING A DRESSING CHANGE. THE CLINICIAN STATED THAT THE HYDROPICC WAS IMPLANTED ON (B)(6) 2020 WITHOUT ISSUE, AND "EXCELLENT BLOOD FLOW" WAS CONFIRMED AT THE COMPLETION OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICIAN WAS NOTIFIED THAT THE HYDROPICC "WASN'T WORKING, REPOSITIONING THE INFUSION RESULTED IN LEAKING AT SITE." WHEN THE CLINICIAN ARRIVED ON SITE, THEY "SUTURED CUT LINE PULLED BACK AT [SIC] FOUND TO BE KINKED AND CRACKED AT THE SUTURE WING STEM/CATHETER JUNCTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606551 HYDROPICC PERIPHERALLY INSERTED CENTRAL CATHETER LJS ACCESS VASCULAR, INC. PICC-142 04172001 00862559000418

    Patients

    Seq Age Sex Outcome Treatment
    1 Other