BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3760960 · Received April 11, 2014

    Report

    Report Number
    1036844-2014-00174
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJS
    PMA / PMN Number
    K042126
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PICC LINE WAS BEING REMOVED AFTER 219 DAYS IN SITU; ORIGINALLY PLACED (B)(6) 2013. THE USER REPORTED THAT THERE WAS DIFFICULTY REMOVING THE PICC LINE. THERE WAS NO REPORTED DELAY, HARM, DEATH, COMPLICATIONS, OR INJURY TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. MEDICAL INTERVENTION WAS REPORTED AS IT WAS NECESSARY TO HAVE THE VASCULAR CONSULTANT CALLED IN TO AID IN THE REMOVAL OF THE PICC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220572 PICC SET: 4 FR X 19-1/2" (50 CM) PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention