BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE LUMEN 1.4 FR POLYURETHANE PICC

    MDR report key: 7975856 · Received October 17, 2018

    Report

    Report Number
    3007697249-2018-09001
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    June 20, 2018
    Report Date
    October 16, 2018
    Manufacturer
    FOOTPRINT MEDICAL, INC.
    Product Code
    LJS
    PMA / PMN Number
    K130507
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT NUMBER, 18C013D, IS NOT A FOOTPRINT MEDICAL INC. LOT NUMBER. HOWEVER, THE COMPLAINT PRODUCT RECEIVED WAS VERIFIED TO BE A FOOTPRINT MEDICAL INC. MANUFACTURED 1.4FR POLYURETHANE PICC. IT IS PROBABLE THAT THE CATHETER FAILED DUE TO KINKING OF THE CATHETER BODY TUBING UNDERNEATH THE DRESSING THAT LED TO PREMATURE FAILURE OF THE CATHETER. THE TUBING IS RECEIVED WITH A NOTABLE BEND STILL APPARENT AT THE STRAIN RELIEF. THE LOCATION OF THE TEAR BEING AT THE CREASE OF THE BEND IS MOST LIKELY THE RESULT OF BEING SECURED IN A KINKED POSITION. THE CATHETER PERFORMED AS EXPECTED FOR 48 DAYS. BASED ON THE EVALUATION OF THE RETURNED DEVICE, IT IS REASONABLE TO CONCLUDE THAT THE CATHETER FAILURE IS NOT RELATED TO THE MANUFACTURE OF THE DEVICE.

    Description of Event or Problem · 1

    A 1.4FR POLYURETHANE PIC CATHETER WAS DISCOVERED TO BE LEAKING IMMEDIATELY BELOW THE SECUREMENT PLATFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813248 SINGLE LUMEN 1.4 FR POLYURETHANE PICC PICC, PERCUTANEOUS, PERIPHERALLY INSERTED CENTRAL CATHETER LJS FOOTPRINT MEDICAL, INC. P1PIC1.4-S

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA