BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTIMICROBIAL PICC KIT 2 LUMEN: 5.5 FR X

    MDR report key: 3130212 · Received May 22, 2013

    Report

    Report Number
    1036844-2013-00179
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJS
    PMA / PMN Number
    K112896
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS PLACED INTO THE PATIENT'S RIGHT BASILICA VEIN IN THE CRITICAL CARE UNIT. THE CLINICIAN HAD TO EXCHANGE THE CATHETER DUE TO DISTAL LUMEN OCCLUSION. IT WAS UNRESPONSIVE TO TPA X 3 DOES (INSERTED 2 DAYS PRIOR, INR WAS 4.4). UPON INSPECTION OF BLUE FLEX TIP AT REMOVAL, THE CLINICIAN NOTICED A CHIP MISSING FROM THE BLUE TIP. THE BLUE FLEX TIP WAS INTACT PRIOR TO PLACEMENT. THE PT DID NOT HAVE ANY OTHER DEVICES PLACED THAT MAY HAVE INTERFERED WITH THE CATHETER, HOWEVER, THE PATIENT DID HAVE A TUMOR LOCATED IN THE CHEST AREA THAT MAY HAVE PROVIDED VESSEL/CATHETER OBSTRUCTION. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED. THE CLINICIAN CONFIRMED THERE WAS NO EVIDENCE OR COMPLICATIONS SEEN WITH THE PATIENT THAT INDICATED A PIECE WAS LEFT INSIDE THE PATIENT. NOTHING WAS SURGICALLY REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226470 ANTIMICROBIAL PICC KIT 2 LUMEN: 5.5 FR X PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTL., INC. RF2072694

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK