BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAS-CATH SOFT-CELL KIT 12.5 F X 19 CM (PRE-CURVED LONG TERM D

    MDR report key: 1914208 · Received December 1, 2010

    Report

    Report Number
    3006260740-2010-00354
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    September 8, 2010
    Report Date
    November 18, 2010
    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 AT THIS TIME FOR EVAL. A CHR REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    CATHETER WAS SMOOTHLY REMOVED AND THE DISLODGED SURE CUFF REMAINS IN A PT BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAS-CATH SOFT-CELL KIT 12.5 F X 19 CM (PRE-CURVED LONG TERM D LFJ C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention