BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 1932142 · Received December 14, 2010

    Report

    Report Number
    1625425-2010-00029
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT WHEN SAMPLE IS RETURNED.

    Description of Event or Problem · 1

    PICC LINE WAS PLACED WITHOUT INCIDENT IN THE PT. INITIAL TIP CONFIRMATION X-RAY WAS TAKEN AND THE PICC TIP WAS IN THE APPROPRIATE LOCATION. THERE WAS NO EXTERNAL MIGRATION NOTED UPON ASSESSMENT OF PICC SITE. AT 24 HRS AFTER THE PICC WAS PLACED, THE PT BECAME COMPROMISED, CHEST X-RAY TAKEN, UPON REVIEW OF X-RAY THE PICC WAS DEEPER THAN ON THE INITIAL X-RAY 24 HRS EARLIER. PT DIAGNOSED WITH PERICARDIAL TAMPONADE, PT CODED, THE MEDICAL TEAM CODED THE PT, PT SURVIVED CODE. A PERICARDIOCENTESIS WAS PERFORMED, PICC PULLED BACK TO APPROPRIATE LOCATION. CONFIRMATION X-RAY TAKEN WHICH CONFIRMED PICC TIP IN APPROPRIATE LOCATION. PICC LINE LEFT IN DWELLING IN PT AND IS INFUSING IV FLUIDS WITHOUT INCIDENT. PT IS CLINICALLY DOING GOOD, NO ADVERSE OUTCOME TO PT PER THIS EVENT. THE MEDICAL TEAM BELIEVES THE PT WAS CONTRACTED DURING AND AFTER PICC INSERTION, THEN PT RELAXED, AND THIS IS THE RATIONALE FOR THE PICC TIP LOCATION BEING DEEPER THAN ON THE INITIAL TIP CONFIRMATION X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC FOZ ARGON MEDICAL DEVICES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R