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: 1935974 · Received December 8, 2010

    Report

    Report Number
    3006260740-2010-00369
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    September 8, 2010
    Report Date
    December 2, 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 MANUFACTURER FOR EVALUATION. A CHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    SURE CUFF DISLODGEMENT WAS FOUND. WHEN THE USER TRIED TO REMOVE THE TEMPORALLY USED CATHETER, THE SURE CUFF DISLODGED FROM THE CATHETER. DURING THE INCIDENT ONLY CATHETER WAS SMOOTHLY REMOVED AND THE DISLODGED SURE CUFF REMAINED 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