BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS TRAY

    MDR report key: 3810674 · Received March 24, 2014

    Report

    Report Number
    1036844-2014-00138
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 20, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJS
    PMA / PMN Number
    K930129
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE RADIOLOGY DEPARTMENT, THE USER FOUND THAT THE ORANGE TAB FROM THE PEEL-AWAY SNAPPED OFF OF THE SHEATH WHILE IT WAS BEING REMOVED FROM THE PATIENT'S LEFT BASILIC ACF VEIN. ASA RESULT, THE USER WAS ABLE TO TEAR THE SHEATH BY PULLING THE CATHETER AWAY FROM THE SHEATH. THERE WAS NO DELAY, DEATH, OR COMPLICATIONS REPORTED AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172769 ACCESS TRAY PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTL., INC. 23F13H0148

    Patients

    Seq Age Sex Outcome Treatment
    1