BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICC SET: 3-LUMEN 6 FR X 50 CM

    MDR report key: 4202442 · Received September 18, 2014

    Report

    Report Number
    3006425876-2014-00197
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 18, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    PMA / PMN Number
    K080604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS PRODUCT NUMBER IS NOT SOLD IN THE USA. HOWEVER, THE CATHETER INVOLVED IS SOLD IN OTHER PRODUCTS WITHIN THE US. THE 510(K) NUMBER PROVIDED IS FOR THE PRODUCTS SOLD WITHIN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS EVENT OCCURRED IN THE ICU DEPARTMENT. AS THE PATIENT WAS BEING TURNED, THE PICC "SNAPPED AT THE HUB JUNCTURE." THE USER REPORTS THAT THERE WAS "STRETCHED AND TENSION ON THE LINE WHEN IT SNAPPED." THE CATHETER WAS CLAMPED AND THE PICC WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S RIGHT ARM. AS A RESULT, A NEW PICC WAS INSERTED SUCCESSFULLY. THERE WAS A DELAY REPORTED, HOWEVER, NO HARM TO THE PATIENT AS A RESULT OF THE DELAY. THERE WERE NO COMPLICATIONS, DEATH, OR INJURY REPORTED TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578803 PICC SET: 3-LUMEN 6 FR X 50 CM PERIPHERALLY INSERTED CENTRAL CATHETER LJS ARROW INTERNATIONAL INC. 71F14C0161

    Patients

    Seq Age Sex Outcome Treatment
    1