BEUDAMED
    FDA Adverse Event Death Summary report: N

    L-CATH 26G (1.9F)0.60MM X 30CM

    MDR report key: 5539734 · Received March 31, 2016

    Report

    Report Number
    1625425-2016-00004
    Event Type
    Death
    Date Received
    March 31, 2016
    Date of Event
    February 3, 2016
    Report Date
    March 30, 2016
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K091670
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER INFORMATION RECEIVED BY THE SALES REPRESENTATIVE FROM THE CUSTOMER, THIS COMPLAINT WAS NOT DUE TO A PRODUCT ISSUE. THIS WAS A HUMAN ERROR IN REGARDS TO CARE/MAINTENANCE OF THE PICC. AN EDUCATION/TRAINING HAS BEEN SCHEDULED. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    NOTIFIED BY CUSTOMER THAT THERE WAS A BIO-PATCH OVER THE PICC INSERTION SITE. FOUR (4) CM OF PICC MIGRATED INWARD AND PATIENT EXPERIENCED A PERICARDIAL TAMPONADE. PATIENT DIED. PER CUSTOMER, THIS IS NOT A PRODUCT ISSUE. THIS WAS A HUMAN ERROR IN REGARDS TO CARE/MAINTENANCE OF THE PICC. NO OTHER DETAILS WAS PROVIDED BY THE CUSTOMER. PER MEDWATCH REPORT (B)(4) WHICH WAS RECEIVED ON MARCH 21, INFANT HAD A PICC LINE PLACES ON (B)(6) 2016, WHICH HAS NOTED TO HAVE MIGRATED INTO THE HEART AND REPOSITIONED ON TWO OCCASIONS. ON (B)(6) 2016 HAD A SUDDEN ARREST AND EXPIRED. AUTOPSY REVEALED A PERICARDIAL EFFUSION WITH FLUID CONSISTENT WITH TOTAL PARENTERAL NUTRITION SOLUTION. NOTE: IT WAS CONFIRMED THAT THIS MEDWATCH REPORT WAS THE SAME COMPLAINT THAT WE HAD ALREADY RECEIVED AND ENTERED IN OUR COMPLAINT DATABASE UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195299 L-CATH 26G (1.9F)0.60MM X 30CM L-CATH FOZ ARGON MEDICAL DEVICES, INC. 11122897

    Patients

    Seq Age Sex Outcome Treatment
    1 Death