BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW

    MDR report key: 5110637 · Received September 29, 2015

    Report

    Report Number
    5110637
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    August 11, 2015
    Report Date
    September 1, 2015
    Manufacturer
    ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PEEL AWAY SHEATH OVER DILATOR UNIT WAS THREADED OVER WIRE DURING PICC CATHETER INSERTION. THE DILATOR AND WIRE WERE REMOVED. PICC INSERTED TO THE PREMEASURED 44 CM. THE WINGS OF THE DILATOR SNAPPED AS PER MANUFACTURER INSTRUCTIONS. ONE WING BROKE OFF FROM THE WINGS AND SHEATH, AND THE SHEATH DID NOT SPLIT AS IT IS SUPPOSED TO DO. THE SHEATH WAS REMOVED FROM THE VENIPUNCTURE SITE, FORCEPS WERE USED TO COMPLETE THE SHEATH SPLIT AND REINSERT THE PICC FULLY TO THE PREMEASURED 44CM. THE CATHETER WITH THE SHEATH WAS PULLED BACK 10CM AND THE SHEATH WAS MANUALLY SPLIT AND REMOVED. THE CATHETER WAS REINSERTED TO FULL MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640734 ARROW PICC KIT LJT ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) 23F15F0281

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR