BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD L-CATH PICC AND BD SPLITTABLE NEEDLE INTRODUCER

    MDR report key: 1850180 · Received September 22, 2010

    Report

    Report Number
    1850180
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    July 18, 2010
    Report Date
    July 22, 2010
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT PREPPED FOR PICC LINE PLACEMENT. PICC REMOVED FROM PACKAGE AND NOTED THAT THE GUIDE WIRE DID NOT EXTEND TO THE END OF THE CATHETER. THE GUIDE WIRE ENDED APPROXIMATELY 1.75 INCHES BEFORE THE END OF THE CATHETER. THE NURSE PLACING THE PICC CHECKED TO MAKE CERTAIN THE PICC WOULD ADVANCE THROUGH THE INTRODUCER NEEDLE BEFORE STARTING THE PROCEDURE, NOTING THE ISSUE BEFORE IT INVOLVED THE PATIENT. THE CATHETER WOULD NOT ADVANCE CORRECTLY AND THEREFORE REPLACED.HAD THE CATHETER NOT BEEN CHECKED BEFORE INSERTION, THE PATIENT MAY HAVE HAD TO HAVE A REPEAT PROCEDURE (NEEDLE PUNCTURE). THE PATIENT MAY HAVE LOST ADDITIONAL BLOOD HAD THE NEEDLE BEEN INSERTED SUCCESSFULLY AND THEN THE CATHETER COULD NOT BE PLACED, NECESSITATING SOMEONE TO RETRIEVE ANOTHER CATHETER. IN ADDITION THERE WAS A DELAY IN THERAPY UNTIL THE LINE COULD BE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD L-CATH PICC AND BD SPLITTABLE NEEDLE INTRODUCER CATHETER, PICC LJS BECTON DICKINSON AND COMPANY * 0109939

    Patients

    Seq Age Sex Outcome Treatment
    1 95 DA NO OTHER THERAPIES