BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD

    MDR report key: 533033 · Received June 4, 2004

    Report

    Report Number
    MW1032370
    Event Type
    Malfunction
    Date Received
    June 4, 2004
    Date of Event
    May 6, 2004
    Report Date
    June 4, 2004
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SAFETY, RETRACTABLE DERMATOTOMY TOOL (BLADE/SCAPEL) PROVIDED IN THE BARD ACCESS SYSTEMS SAFETY UNIVERSAL MICRO-INTRODUCER KIT HAS BEEN FAILING TO RETRACT FULLY. ONE NURSE SUSTAINED A SHARPS INJURY DUE TO THE FAILURE TO FULLY RETRACT.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/23/04: THE REPORTED EVENT IN THE MEDICAL DEVICE REPORT IS ATTRIBUTABLE TO THE SAFETY SCALPEL THAT IS CONTAINED IN THE KIT MANUFACTURED BY BARD ACCESS SYSTEMS. OUR INVESTIGATION HAS REVEALED THAT THIS IS A SUPPLIER RELATED ISSUE AND THE 'NOT COMPLETE RETRACTION OF THE BLADE' IS AN INTERMITTENT AND RANDOM OCCURRENCE. AT THIS TIME, WE HAVE INSTITUTED A 100% FUNCTIONAL INSPECTION OF THE SCALPEL AT OUR MANUFACTURING FACILITY UNTIL THE SUPPLIER IDENTIFIES A ROOT CAUSE AND IMPLEMENTS CORRECTIVE ACTION(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD SAFETY UNIVERSAL MICRO INTRODUCER KIT LRO BARD ACCESS SYSTEMS 0678950 22C04699
    2 BARD SAFETY UNIVERSAL MICRO INTRODUCER KIT LRO BARD ACCESS SYSTEMS 0678950 22C04734

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other