BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICC SET: 4 FR X 19-1/2IN (50 CM)

    MDR report key: 2031395 · Received March 23, 2011

    Report

    Report Number
    1036844-2011-00096
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 8, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    LJS
    PMA / PMN Number
    K930129
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE MEDICAL WARD A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WAS BEING PLACED VIA THE LEFT BASILIC VEIN BY AN ANESTHESIA PHYSICIAN. THE NEEDLE WAS PLACED INTO THE VEIN AND THEN AN ATTEMPT WAS MADE TO PASS THE SPRING WIRE GUIDE (SWG) THROUGH THE NEEDLE. RESISTANCE WAS FELT AFTER A PORTION OF THE SWG WAS PASSED. WHEN RETRACTING THE SWG THROUGH THE NEEDLE WITH NO MORE FORCE THEN NORMAL, THE FLOPPY PORTION OF THE SWG BEGAN TO UNRAVEL AND DETACH FROM THE SOLID CORE. A PORTION OF THE SWG REMAINED IN THE PT AND HAD TO BE SURGICALLY CAPTURED AND REMOVED. THERE IS NO REPORTED DEATH OR POST OP COMPLICATIONS, EXCEPT THE PAIN AND DISCOMFORT ENDURED BY THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICC SET: 4 FR X 19-1/2IN (50 CM) PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTERNATIONAL INC RF8016723

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention