BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR S/L GROSHONG NXT CLEARVUE BASIC KIT W/MICROINTRODUCER

    MDR report key: 3042941 · Received March 7, 2013

    Report

    Report Number
    3006260740-2013-00090
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT OF A "V" SHAPED SLIT IN THE TUBING IS CONFIRMED. THE SLIT IN THE TUBING IS LOCATED AT THE 8 CM DEPTH MARKER. THIS PRODUCT CONTAINS DAMAGE CHARACTERISTICS THAT WOULD SUGGEST CONTACT WITH A SHARP IMPLEMENT. HOWEVER, THE LONGEVITY OF THE DEVICE, INCOMPLETE INFORMATION SUGGEST ANOTHER (OTHER) FACTOR(S) WAS (WERE) INVOLVED. AT THIS TIME THE MECHANISM OF THE DAMAGE IS UNDETERMINED. A LOT HISTORY REVIEW (LHR) OF REWE0877 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    KNICK FOUND IN CATHETER DURING INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98329 4 FR S/L GROSHONG NXT CLEARVUE BASIC KIT W/MICROINTRODUCER LJS C. R. BARD INC. (BASD) REWE0877

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention