BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTABLE SAFETY SCALPEL

    MDR report key: 5291116 · Received December 11, 2015

    Report

    Report Number
    3004605321-2015-00017
    Event Type
    Malfunction
    Date Received
    December 11, 2015
    Date of Event
    November 12, 2015
    Report Date
    December 11, 2015
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    GDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS: THE REPORTED ISSUE HAS BEEN DETERMINED TO BE A RANDOM EVENT. THE DEFECTIVE SCALPEL WAS NOT RETURNED FOR EVALUATION. IT IS UNKNOWN WHETHER THE ISSUE OCCURRED DUE TO PRE-ACTIVATION OF THE SCALPEL BLADE. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: DUE TO THE INVESTIGATION AND ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED INDICATING THAT AN EMPLOYEE WAS STUCK IN THE FINGER BY A SCALPEL BLADE (PART NUMBER (B)(4)) UPON ATTEMPTING TO REMOVE THE DEVICE FROM THE PACKAGING. A SAMPLE OF THE DEFECTIVE DEVICE WAS NOT RETURNED TO DEROYAL FOR EVALUATION. THE QUALITY CONTROL COMPLAINT SPECIALIST REVIEWED THE ROUTING INSTRUCTIONS FOR PART NUMBER (B)(4) ABOUT THE DEVICE PACKAGING. THE ROUTING INSTRUCTIONS STATE THE FOLLOWING: "ASSURE THE BLADE IS COMPLETELY RETRACTED PRIOR TO PACKAGING. PLACE 100 EACH SCALPELS IN A DOUBLE POLYBAG. MAKE SURE THE SCALPELS ARE ALL TURNED IN THE SAME DIRECTION. TWIST TIE AND POLY LINERS SHALL BE CLOSED AS FIRMLY AROUND SCALPELS AS POSSIBLE. PLACE TWO POLYBAGS WITH 100 EACH SCALPELS IN THE SHIPPER CASE WITH SHARP END TOWARD EACH END OF THE BOX. PLACE ONE EACH INSERT PER CASE. PLACE OUTER CARTON LABEL ON OUTER BOX." BY PACKAGING THE PRODUCT IN THE ABOVE MENTIONED MANNER, THE DEVICES CAN BE REMOVED FROM THE SHIPPING CASE WITH THE BLADES FACING AWAY FROM THE END USER. (B)(4). PREVENTIVE ACTION: DUE TO THE INVESTIGATION AND ROOT CAUSE DETERMINATION, A PREVENTIVE ACTION HAS NOT BEEN TAKEN. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CARDINAL PERSONNEL WAS READY TO OPEN A BAG CONTAINING PART (B)(4). THE EMPLOYEE WAS STUCK IN THE FINGER BY A BLADE THAT WAS STICKING OUT OF THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818886 RETRACTABLE SAFETY SCALPEL HANDLE, SCALPEL GDZ DEROYAL INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1