BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.9 FR SL PICC

    MDR report key: 10074652 · Received May 19, 2020

    Report

    Report Number
    MW5094567
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    May 8, 2020
    Report Date
    May 15, 2020
    Manufacturer
    NEO MEDICAL INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH A 1.9FR SL LOWER EXTREMITY PICC LINE BROKEN OFF AND REMAINING IN RIGHT GROIN VENOUS SYSTEM. RIGHT GROIN EXPLORATION OCCURRED TO REMOVE PICC FRAGMENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536790 1.9 FR SL PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS NEO MEDICAL INC. 1.9FR SL PICC 191207
    536792 FOOTPRINT PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS FOOTPRINT MEDICAL INC. P1PIC1.9-S

    Patients

    Seq Age Sex Outcome Treatment
    1 10 WK Other