BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDLINE CATHETERIZATION KIT: 4 FR X 8 (

    MDR report key: 3061264 · Received April 10, 2013

    Report

    Report Number
    1036844-2013-00147
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJS
    PMA / PMN Number
    K963257
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED IN THE SPECIAL PROCEDURES ROOM. DURING INSERTION, WHEN THEY ATTEMPTED TO PEEL THE SHEATH FROM THE CATHETER, THE ORANGE HANDLES ON THE SHEATH SEPARATED FROM THE SHEATH. THE INSERTING NURSE WAS ABLE TO REMOVE THE SHEATH FROM THE INSERTION SITE WITHOUT HARM TO THE PT AND THE CATHETER WAS LEFT IN PLACE. THERE WAS NO DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148397 MIDLINE CATHETERIZATION KIT: 4 FR X 8 ( MIDLINE CATHETERS LJS ARROW INTL., INC. RF3014724

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK