BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDCOMP 2.6F X 50CM DUAL LUMEN VASCU-PICC BASIC SET, PICC LINE

    MDR report key: 8189883 · Received December 20, 2018

    Report

    Report Number
    MW5082412
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 18, 2018
    Report Date
    December 19, 2018
    Manufacturer
    MEDICAL COMPONENTS INC., (DBA MEDICOMP)
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH 2.6F PICC LINE, WHITE LUMEN NOT FLUSHING. DOSE OF TPA USED WHICH WAS UNSUCCESSFUL. WHEN PICC LINE DISCONTINUED, THERE WAS A HOLE IN THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027454 MEDCOMP 2.6F X 50CM DUAL LUMEN VASCU-PICC BASIC SET, PICC LINE CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS MEDICAL COMPONENTS INC., (DBA MEDICOMP) REF MR17012601 MLGM710

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO