BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDLINE CATHETERIZATION SET

    MDR report key: 3250079 · Received July 24, 2013

    Report

    Report Number
    3006425876-2013-00136
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    May 6, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    PMA / PMN Number
    K963257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS PLACED IN THE LEFT ANTICUBETICAL FOSSA (ACF) TO 20CM AND DISCHARGED WITH ONCE A DAY BOLUS THERAPY. LEAKING FROM THE ENTRY POINT DURING ADMINISTRATION OCCURRED AFTER FIVE DAYS OF BEING INSITU. AS A RESULT, THE CATHETER WAS REMOVED AND A PICC WAS INSERTED. THERE WAS NO REPORTED PATIENT INJURY, COMPLICATIONS, OR DEATH. THERE WAS A DELAY IN TREATMENT, BUT IT DID NOT CAUSE HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345540 MIDLINE CATHETERIZATION SET MIDLINE CATHETERS LJS ARROW INTERNATIONAL INC. ZF1091614

    Patients

    Seq Age Sex Outcome Treatment
    1