BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR SL POWERPICC SOLO CATHETER, BASIC

    MDR report key: 2971583 · Received January 30, 2013

    Report

    Report Number
    3006260740-2013-00039
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    November 20, 2012
    Report Date
    January 7, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K072230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REWH0379 SHOWED ONE OF OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER((B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IN FOR PICC CARE AND UPON FLUSHING, LEAKING WAS NOTED AT THE INSERTION SITE. THE PICC WAS PULLED FURTHER 1-2 CM AND INSTILLED FLUID AND LEAKING WAS NOTED AT THE 10-11 CM MARK. PICC REMOVED AND ANOTHER PICC WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41880 4 FR SL POWERPICC SOLO CATHETER, BASIC LJS C. R. BARD INC. (BASD) REWH0379

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention