BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROEZ UNIVERSAL MI KIT, 5 FR ANL, 5 CM, SS

    MDR report key: 3043022 · Received March 7, 2013

    Report

    Report Number
    3006260740-2013-00110
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    December 3, 2012
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    DYB
    PMA / PMN Number
    K915167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A KNOT IN THE GUIDEWIRE WAS CONFIRMED BUT THE CAUSE IS UNK. THE PRODUCT RETURNED FOR EVAL WAS A GUIDEWIRE. THE GUIDEWIRE WAS UNREMARKABLE EXCEPT FOR A KNOT LOCATED 0.2" FROM THE DISTAL END OF THE SAMPLE. MICROSCOPE EXAMINATION REVEALED THAT THE COILS ALONG THE COIL WIRE WERE SLIGHTLY DISPLACED NEAR THE KNOT IN THE WIRE. THE EXACT MECHANISM WHICH CAUSED THE GUIDEWIRE TO GET A KNOT IS UNK AT THIS TIME. A LOT HISTORY REVIEW (LHR) OF REWG0569 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PICC INSERTER ATTEMPTED TO REMOVE THE GUIDEWIRE, RESISTANCE WAS FELT. COULD NOT REMOVE THE DERMATOTOMY PERFORMED. ATTEMPTED TO REMOVE THE GUIDEWIRE AGAIN WITH LESS RESISTANCE, PULLED FIRMLY TO REMOVE. ONCE REMOVED, A SMALL KNOT WAS NOTED AT THE END OF THE GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98420 MICROEZ UNIVERSAL MI KIT, 5 FR ANL, 5 CM, SS DYB C. R. BARD INC. (BASD) REWG0569

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention