BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 14 FR X 15 CM

    MDR report key: 2436937 · Received January 18, 2012

    Report

    Report Number
    1036844-2012-00024
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Date of Event
    January 2, 2012
    Report Date
    January 17, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    MPB
    PMA / PMN Number
    K991431
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN ANESTHESIA, THE MD MET WITH SEVERE RESISTANCE WHEN ATTEMPTING TO ADVANCE THE SWG THROUGH THE ARS IN THE PT'S JUGULAR VEIN. THE MD PULLED BACK ON THE SWG TO REMOVE IT FROM THE SYRINGE AND AT THAT TIME THE SWG "STRETCHED". AS A RESULT, BOTH THE SWG AND ARS WERE REMOVED AND A NEW KIT WAS OPENED AND USED IT WITHOUT ISSUE. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO DEATH OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 14 FR X 15 CM ACUTE HEMODIALYSIS CATHETER PRODUCTS MPB ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK