BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIAGARA SLIM-CATH 20 CM STRAIGHT KIT

    MDR report key: 2013829 · Received February 4, 2011

    Report

    Report Number
    3006260740-2011-00033
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Report Date
    February 1, 2011
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    MPB
    PMA / PMN Number
    K010778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS LEAK IN THE CATHETER, CAUSING PROBLEMS OF SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIAGARA SLIM-CATH 20 CM STRAIGHT KIT MPB C. R. BARD, INC. (BASD) REUE0033

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention