BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1ST PICC S/L 26GA (1.9F)

    MDR report key: 4264634 · Received October 29, 2014

    Report

    Report Number
    1625425-2014-00035
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    August 18, 2014
    Report Date
    October 29, 2014
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DYB
    PMA / PMN Number
    K020834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATES THAT RESISTANCE WAS EXPERIENCED DURING THE INSERTION OF THE INTRODUCER AND BLEEDING ON THE PATIENT'S LUNG WAS OBSERVED. THE INSERTION SITE OF THE INTRODUCER AND THE SEQUENCE OF EVENTS WHICH LED TO THE BLEEDING WAS REQUESTED FROM THE CUSTOMER BUT WAS NOT RECEIVED. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER FOR THE COMPLAINT INTRODUCER WAS NOT PROVIDED. THE INTRODUCER (INTROSYTE-N) IS USED TO GAIN PERIPHERAL IV ACCESS. DURING VENIPUNCTURE, THE INTRODUCER IS THREADED AND THE NEEDLE IS INSERTED INTO THE VESSEL, BUT MOST PART OF THE INTRODUCER REMAINS OUTSIDE OF THE PATIENT. THEREFORE, IT WOULD BE IMPROBABLE THAT THE INTRODUCER WOULD MIGRATE AND CAUSE HEMORRHAGE TO THE LUNG. IT IS POSSIBLE THAT THE COMPLAINT WAS RELATED TO THE CATHETER AND NOT THE INTRODUCER AS STATED IN THE PROBLEM DESCRIPTION. THE ROOT CAUSE IS INCONCLUSIVE BECAUSE THE INSERTION SITE WAS NOT PROVIDED. IF ADDITIONAL INFO IS PROVIDED, THE COMPLAINT INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    RESISTANCE WAS FOUND DURING INSERTION OF INTRODUCER, AND THERE WAS HEMORRHAGE IN PATIENT'S LUNG DURING INSERTION. THE TIP OF INTRODUCER WAS FOUND DAMAGED AFTER TAKEN OUT FROM BLOOD VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691128 1ST PICC S/L 26GA (1.9F) FIRST PICC DYB ARGON MEDICAL DEVICES INC. NA FOR INTRODUCER

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention