BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2961210 · Received February 8, 2013

    Report

    Report Number
    3006260740-2013-00059
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    September 11, 2012
    Report Date
    January 2, 2013
    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 MFR AT THIS TIME FOR EVALUATION. A LOT HISTORY REVIEW (LHR )OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THERE WAS DISRUPTION OF THE CATHETER INSIDE THE CUFF. ADDITIONAL INFORMATION: THE FACILITY REPORTS THAT THE CATHETER BREAK OCCURRED INSIDE THE SUTURE WING ABUT THAT IT WAS A SUBCUTANEOUS BREAK. THE CATHETER DID NOT EMBOLIZE INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54608 2 FR PER-Q-CATH PLUS PICC WITH STYLET, BASIC LJS C. R. BARD INC. (BASD) REWA1394

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention