BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICC SET

    MDR report key: 2172569 · Received July 20, 2011

    Report

    Report Number
    1036844-2011-00234
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    MEH
    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). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE OPERATING THEATRE, THE CLINICIAN TRIED TO WITHDRAW THE SPRING WIRE GUIDE (SWG) BACK THROUGH THE NEEDLE THAT WAS PLACED IN THE PT'S RIGHT BASILIC VEIN. IT WAS AT THAT TIME, THE SWG "SHEARED" AND PART OF IT REMAINED IN THE PT'S VEIN. AS A RESULT, THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL TO HAVE THE FRAGMENT OF SWG THAT REMAINED IN THE PT REMOVED. THERE WAS NO DEATH OR COMPLICATIONS TO THE PT AS A RESULT OF THIS OCCURRENCE. ADDITIONAL INFO RECEIVED ON (B)(6) 2011 FROM THE DISTRIBUTOR STATED THAT THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL AND IT WAS VERIFIED THAT ALL FRAGMENTS WERE SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICC SET PERIPHERALLY INSERTED CENTRAL CATHETERS MEH ARROW INTERNATIONAL INC RF0062087

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention