BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 FR PER-Q-CATH PLUS PICC WITH STYLET, INTERMEDIATE

    MDR report key: 1993617 · Received January 6, 2011

    Report

    Report Number
    3006260740-2011-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 13, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K954104
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVALUATION. A CHR OF LOT #REUG0685 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    PICC LINE BROKE WHILE ATTEMPTING TO REMOVE IT. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2 FR PER-Q-CATH PLUS PICC WITH STYLET, INTERMEDIATE LJS C. R. BARD INC. (BASD) REUG0685

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention