BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.4 FR POLYURETHANE PIC CATHETER KIT

    MDR report key: 6811791 · Received August 22, 2017

    Report

    Report Number
    3007697249-2017-07003
    Event Type
    Malfunction
    Date Received
    August 22, 2017
    Date of Event
    July 8, 2017
    Report Date
    August 22, 2017
    Manufacturer
    FOOTPRINT MEDICAL, INC.
    Product Code
    LJS
    UDI-DI
    00858778006072
    PMA / PMN Number
    K-130507
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CATHETER BROKE DUE TO EXCESSIVE FORCE EXPERIENCED BY THE TUBING AT THE MOLDED JUNCTURE HUB. THE HOSPITAL HAS STATED THAT THEY BELIEVE THE EVENT IS "NOT A RESULT OF A DEFECTIVE CATHETER." THERE IS NO INJURY TO THE PATIENT AND THERE WAS NO NEED FOR MEDICAL INTERVENTION BEYOND THE EXTRACTION OF THE CATHETER THROUGH NORMAL MEANS. ORIGINALLY THE LOT NUMBER WAS REPORTED AS #170064, HOWEVER THE HOSPITAL CONFIRMED THE CORRECT LOT NUMBER OF #170230. QUALITY AND MANUFACTURING REVIEW OF LOT #170230 INDICATES PRODUCT WAS MANUFACTURED IN ACCORDANCE WITH APPROVED QUALITY AND MANUFACTURING DOCUMENTATION. THERE ARE CURRENTLY NO OTHER COMPLAINTS ON FILE FROM LOT #170230. AFTER REVIEW OF THE COMPLAINT CATHETER AND COMMUNICATION WITH THE FACILITY, IT IS REASONABLE TO CONCLUDE THAT THE PRODUCT FAILURE IS NOT DUE TO MANUFACTURER DEFECT. A REPORT OF THE FINDINGS HAS BEEN SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE 1.4 FR POLYURETHANE PIC CATHETER BROKE AT THE SECUREMENT HUB DURING ATTEMPTED EXPLANT. THE PICC WAS IN PLACE FOR APPROXIMATELY FIVE DAYS BEFORE THE ADVERSE EVENT. THERE WAS NO HARM TO THE INFANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590495 1.4 FR POLYURETHANE PIC CATHETER KIT PICC, PERCUTANEOUS, PERIPHERALLY INSERTED CENTRAL CATHETER LJS FOOTPRINT MEDICAL, INC. P1PIC1.4-S 170230 00858778006072

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA