BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JIT LAMINECTOMY PACK

    MDR report key: 9125711 · Received September 26, 2019

    Report

    Report Number
    3005011024-2019-00013
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    August 29, 2019
    Report Date
    September 26, 2019
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LRO
    UDI-DI
    00749756281393
    PMA / PMN Number
    K842648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED FOR A CONVENIENCE KIT (PART 89-2569, LOT 50224803) THAT CONTAINED OR TOWELS THAT CREATED LINT DURING A SURGICAL PROCEDURE. A SAMPLE WAS RETURNED 9/4/2019 AND CONFIRMED THE REPORTED ISSUE. THE WORK ORDER FOR THE REPORTED LOT WAS REVIEWED FOR POSSIBLE DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE BILL OF MATERIAL FOR THE KIT WAS REVIEWED AND RAW MATERIAL 1060988 WAS IDENTIFIED AS THE AFFECTED OR TOWEL, WHICH IS PURCHASED IN BULK FROM A SUPPLIER, S2S GLOBAL. A SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN SENT TO S2S GLOBAL. THE RETURNED SAMPLE ALSO WAS FORWARDED TO THE SUPPLIER FOR EVALUATION. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    FUZZ ON THE OR TOWELS CAUSED LINT DURING A SURGICAL PROCEDURE. THE OR TOWELS WERE PACKAGED IN A CONVENIENCE KIT USED DURING A NEUROLOGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919445 JIT LAMINECTOMY PACK GENERAL SURGERY TRAY LRO DEROYAL INDUSTRIES, INC. 89-2569 50224803 00749756281393

    Patients

    Seq Age Sex Outcome Treatment
    1