BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTIMICROBIAL PICC KIT 2-LUMEN: 5.5 FR X

    MDR report key: 2455441 · Received February 7, 2012

    Report

    Report Number
    1036844-2012-00032
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Date of Event
    January 20, 2012
    Report Date
    February 8, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJS
    PMA / PMN Number
    K100635
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS BEING PLACED INTO THE PT¿S ARM. DURING INSERTION, THE CLINICIAN NOTICED THAT THE PEEL-AWAY SHEATH OVER DILATOR BECAME BENT AT THE TIP AND DID NOT MOVE FORWARD EASILY. THE PT COMPLAINED OF A LOT OF PRESSURE AND PAIN AT THAT POINT. AS A RESULT, EVERYTHING WAS REMOVED AND AN ¿MST TRAY¿ WAS USED SUCCESSFULLY FOR THE PT. THERE WAS A DELAY IN TREATMENT WITH NO HARM TO THE PT, NO PT DEATH, AND NO PT COMPLICATIONS WERE REPORTED. THE PT OUTCOME WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTIMICROBIAL PICC KIT 2-LUMEN: 5.5 FR X PERIPHERAL CATHETER PRODUCTS LJS ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK