BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAS-CATH SOFT-CELL KIT 12.5 F X 23 CM (PRE-CURVED LONG TERM)

    MDR report key: 2947090 · Received January 30, 2013

    Report

    Report Number
    3006260740-2013-00036
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    November 15, 2012
    Report Date
    January 9, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LFJ
    PMA / PMN Number
    K871488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FIR EVAL. A LOT HISTORY REVIEW (LHR) OF REVB0073 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    PERFORATION OF RIGHT ATRIUM WAS FOUND. THORACOTOMY WAS PERFORMED TO TREAT THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39997 VAS-CATH SOFT-CELL KIT 12.5 F X 23 CM (PRE-CURVED LONG TERM) LFJ C. R. BARD INC. (BASD) REVB0073

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention