BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL LAPAROTOMY SPONGES

    MDR report key: 1951159 · Received December 3, 2010

    Report

    Report Number
    1060680-2010-00004
    Event Type
    Other
    Date Received
    December 3, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 1, 2010
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    EFQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION TO DETERMINE HOW OUR AUTOMATED SELECTION SYSTEM ALLOWED EXPIRED PRODUCT TO BE SHIPPED, QUALITY CONTROL STAFF FOUND THAT THE ORDER RECEIPT AND REPORTS GENERATED FOR STERILE PRODUCT TO SHIP WERE NOT SYNCHRONIZED CORRECTLY. THIS DISCONNECT OCCURRED DUE TO INACCURATE SYSTEM DATA ENTRY BY PURCHASING PERSONNEL. THIS ERROR HAS RESULTED IN THE CORRECTIVE ACTION OF RETAINING ALL EMPLOYEES RESPONSIBLE FOR DATA ENTRY. QUALIFIED QUALITY PERSONNEL ARE CHARGED TO VERIFY THE EFFECTIVENESS OF THIS ACTION.

    Description of Event or Problem · 1

    AFTER A PROCEDURE, IT WAS NOTICED THAT THE LAPAROTOMY SPONGES HAD BEEN USED PAST THEIR EXPIRATION DATE. THE EXPIRED SPONGES HAD BEEN USED FOR TWO DAYS PRIOR TO NOTICING THE DATE OF EXPIRATION. THE FACILITY HAD RECEIVED A TOTAL OF THIRTEEN CASES OF EXPIRED PRODUCT FROM A DISTRIBUTOR OF THE MFR'S DEVICE. ALL REMAINING EXPIRED LAPAROTOMY SPONGES WERE THROWN OUT. THERE WERE NO KNOW ADVERSE EFFECTS DUE TO USE OF THE EXPIRED PRODUCT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL LAPAROTOMY SPONGES LAPAROTOMY SPONGES EFQ DEROYAL INDUSTRIES, INC. 944574

    Patients

    Seq Age Sex Outcome Treatment
    1