BEUDAMED
    FDA Adverse Event Injury Summary report: N

    #11 SAFETY SCALPEL, NS

    MDR report key: 19940407 · Received August 8, 2024

    Report

    Report Number
    2320762-2023-00013
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    May 9, 2023
    Report Date
    June 8, 2023
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    GDZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY COMPLAINT WAS RECEIVED STATING, "CLEANROOM STAFF MEMBER CUT HER FINGER WHEN REMOVING BAG OF SAFETY SCALPELS FROM BOX. ONE BLADE IN THE PACKAGE WAS OPEN." WHILE THE SAMPLE WAS NOT RETURNED, DEROYAL RECEIVED A PHOTO OF THE DEVICE. DEROYAL INSPECTED WORK ORDERS AND DID AN INVENTORY CHECK OF (B)(4) DEVICES, NO ISSUES WERE FOUND. NO ENGINEERING CHANGES OR CORRECTIVE ACTIONS OR PREVENTIVE ACTIONS (CAPA)'S WERE FOUND RELATING TO THIS ITEM EITHER. A LABELING CHECK WAS PERFORMED, AND NO ISSUES WERE FOUND. IT WAS ALSO FOUND THAT A SPECIFIC LABEL THAT STATES "CAUTION: BLADES MAY BECOME EXPOSED DURING TRANSIT." A COMPLAINT TO SALES RATIO WAS CONDUCTED FROM MAY 2022 TO MAY 2023. WITHIN THAT TIME FRAME DEROYAL SOLD (B)(4) CASES OF THE SAFETY SCALPEL ((B)(4) INDIVIDUAL SAFETY SCALPELS) AND WITHIN THAT TIME FRAME ONLY HAD ONE COMPLAINT. THIS LEADS TO A COMPLAINT TO SALES PERCENTAGE OF (B)(4). ROOT CAUSE: IT WAS DETERMINED THAT THE ISSUE REPORTED WAS DUE TO THE SHIPMENT PROCESS EXPOSING THE BLADE(S). CORRECTIVE AND PREVENTIVE ACTIONS: NO CORRECTIVE OR PREVENTATIVE ACTIONS WERE TAKEN DUE THE DETERMINATION OF THE ROOT CAUSE BEING FROM THE SHIPPING PROCESS AS WELL AS HAVING A LABEL ON THE PRODUCT SPECIFICALLY STATING TO INSPECT PRODUCT FOR THIS ISSUE. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS SURROUNDING THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    CLEANROOM STAFF MEMBER CUT HER FINGER WHEN REMOVING BAG OF SAFETY SCALPELS FROM BOX. ONE BLADE IN THE PACKAGE WAS OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069500 #11 SAFETY SCALPEL, NS HANDLE, SCALPEL GDZ DEROYAL INDUSTRIES, INC. D4511A 57454847

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other