BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREMICATH 1FR PICC

    MDR report key: 4048348 · Received April 7, 2014

    Report

    Report Number
    2245270-2014-00030
    Event Type
    Death
    Date Received
    April 7, 2014
    Date of Event
    September 28, 2012
    Report Date
    April 3, 2014
    Manufacturer
    VYGON CORP.
    Product Code
    LJS
    PMA / PMN Number
    K954302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS MALFUNCTION OCCURRED IN 2012, IT IS BEING REPORTED TO FDA AS A RESULT OF A 483 AUDIT OBSERVATION REGARDING MDR REPORTING GIVEN TO VYGON (B)(4) ON (B)(4) 2014. THIS COMPLAINT IS NOT CONFIRMED. FROM THE DESCRIPTION OF THE INCIDENT, IT SEEMS AS IF THE CATHETER WAS INSERTED WITHOUT CATHETER TIP POSITION CONTROL. UNFORTUNATELY, THE USER DID NOT IDENTIFY THE PREMATURE BABY'S SYMPTOMS, SO THAT THE PATIENT FINALLY DIED. THE USER OBVIOUSLY IGNORED THE WARNINGS IN THE CATHETER'S IFU REGARDING CARDIAC TAMPONADE AND THE NECESSITY TO AVOID CATHETER TIP PLACEMENT IN THE RIGHT ATRIUM. HAVING CHECKED BATCH HISTORY RECORDS, NO ABNORMALITIES WERE FOUND. DESPITE OF ONE SIMILAR INCIDENT IN (B)(6) 2009 IN THE USA, WHERE THE CATHETER'S TIP WAS PLACED INTO THE RIGHT ATRIUM, NO SIMILAR INCIDENTS OF CARDIAC TAMPONADE WERE REGISTERED WITHIN THE LAST 5 YEARS.

    Description of Event or Problem · 1

    BABY BECAME VERY UNWELL APPROXIMATELY SEVEN DAYS POST PLACEMENT OF PREMICATH FOR TPN. UNIT WERE UNABLE TO RESUSCITATE AND BABY DIED. PREMICATH WAS NOT RETAINED FOR INVESTIGATION. DURING THE POST MORTEM, TPN WAS DISCOVERED WITHIN THE PLEURAL CAVITY. NO X-RAYS OF TIP PLACEMENT AVAILABLE, AS NO CONTROL WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210258 PREMICATH 1FR PICC PUR INTRAVASCULAR CATHETER LJS VYGON CORP. 1261.21 061211GE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death