BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICC KIT: 4 FR X 19-5/8 (50 CM)

    MDR report key: 1063685 · Received June 20, 2008

    Report

    Report Number
    1036844-2008-00104
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJS
    PMA / PMN Number
    K061289
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THIS EVENT INVOLVED A MALE PT WITH A LEFT BASILIC VEIN INSERTION. NURSE WAS CALLED TO ACCESS MISSING HUB. NURSE DID A ROUTINE IN AM AND IT WAS FINE. PT WAS TRANSFERRED TO ANOTHER FLOOR. IT WAS REPORTED HUB/CLAMP WAS MISSING. NURSE IMMEDIATELY CLAMPED LINE AND REPAIRED LINE USING A BARD REPAIR KIT; IT WAS "SUCCESSFUL". PT. HAD CT SCAN, BUT THEY DID NOT INJECT THROUGH IT. CATHETER WAS INFUSING FINE; HOWEVER, STAFF PLANNED TO DO AN OVER THE WIRE EXCHANGE AS SOON AS POSSIBLE. SALES REPRESENTATIVE SPOKE WITH CLINICAL NURSE SPECIALIST TO DISCUSS THIS WITH CUSTOMER. IT WAS AGREED BETWEEN BOTH PARTIES, THAT SOMEONE INADVERTENTLY CUT/DAMAGED CATHETER WHILE TRANSPORTING OR MOVING PT. PT. IS "SAFE", HOWEVER, AN INVESTIGATION WILL BE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICC KIT: 4 FR X 19-5/8 (50 CM) PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTL., INC. RC7095557

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention