BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PER-Q-CATH PLUS SILICONE CVC

    MDR report key: 1081052 · Received July 18, 2008

    Report

    Report Number
    3006260740-2008-00043
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K954104
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER 13 DAYS IN USE, THE CATHETER PRESENTED DISCONNECTED FROM HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PER-Q-CATH PLUS SILICONE CVC LJS C. R. BARD INC. (BASD) RERE0228

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention