BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 FR DL POWERPICC SOLO CATHETER, FULL TRAY WITH TLS

    MDR report key: 1943925 · Received December 1, 2010

    Report

    Report Number
    3006260740-2010-00353
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Report Date
    November 9, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K072230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVALUATION. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT.

    Description of Event or Problem · 1

    THE NURSE USED ULTRASOUND TO ACCESS THE VEIN AND PASSED THE NEEDLE. SHE ATTEMPTED TO PASS THE WIRE AND IT WOULD NOT ADVANCE. SHE REMOVED THE WIRE AND IT UNRAVELED, AND A SMALL SEGMENT WAS RETAINED IN THE PT'S ARM. DUE TO THE FACT THE PT WAS AGITATED, THEY LEFT THE SEGMENT IN THE PT'S ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR DL POWERPICC SOLO CATHETER, FULL TRAY WITH TLS LJS C. R. BARD INC. (BASD) REUI0344

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention