BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 FR DL POWERPICC, NURSING FULL

    MDR report key: 2793699 · Received October 12, 2012

    Report

    Report Number
    3006260740-2012-00360
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    August 17, 2007
    Report Date
    May 18, 2009
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K051672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A LOT HISTORY REVIEW (LHR) OF RERE0898 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    MEDICAL RECORD REVIEW RECEIVED FROM BARD DAVOL, INC. PT'S MEDICAL RECORDS INDICATED THAT PT HAD A PICC LINE PLACED ON (B)(6) 2007 AND DEVELOPED AN INFECTION. THE LINE WAS REMOVED ON (B)(6) 2007. LINE PLACEMENT IN RIGHT BASILIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR DL POWERPICC, NURSING FULL LJS C. R. BARD INC. (BASD) RERE0898

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention