BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR. S/L POWERPICC - NURSING FULL (TLS)

    MDR report key: 1915443 · Received November 4, 2010

    Report

    Report Number
    3006260740-2010-00321
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 13, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K070996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    LINE WAS PREFLUSHED ONCE, WIRE WAS PULLED BACK TO TRIM CATHETER. AFTER INTRODUCER WAS PLACED, THE WIRE AND DILATOR WAS REMOVED, WITH THE PEEL AWAY SHEATH STILL IN PLACE, THE NURSE STARTED TO FEED THE CATHETER. RESISTANCE WAS FELT DURING ADVANCEMENT, THE NURSE REMOVED THE CATHETER AND PLACED IT ON THE STERILE FIELD. THE NURSE TURNED BACK TO THE PATIENT TO DETERMINE WHAT TO DO NEXT AND FOUND THE LAST 2 CM ON THE WIRE STICKING OUT OF THE PEEL AWAY SHEATH. THE NURSE WAS ABLE TO GRAB THE WIRE FROM THE SHEATH. THE STYLET WAS REMOVED FROM THE PICC AND THE LINE WAS PLACED WITHOUT FURTHER COMPLICATIONS. THE LINE HAD GOOD TLS READING. THE LINE WAS BEING PLACED (LEFT SIDE) BECAUSE THE PATIENT HAD PULLED OUT THE ORIGINAL CATHETER (RIGHT SIDE). PT HAS HAD A CLAVICLE FRACTURE, AXILA COMPRESSION (RIGHT). NO DVT HISTORY ON LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR. S/L POWERPICC - NURSING FULL (TLS) LJS C. R. BARD INC. (BASD) REUH0812

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention