BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMC EXTREMITY PACK

    MDR report key: 13660013 · Received March 3, 2022

    Report

    Report Number
    3005011024-2022-00013
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    February 23, 2022
    Report Date
    September 20, 2022
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LRO
    UDI-DI
    00749756363549
    PMA / PMN Number
    K842648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY MEDWATCH REPORT (B)(4) WAS RECEIVED ON 02/23/2022 REPORTING CONTAMINANT INSIDE LID OF SPECIMEN CONTAINER. THE ISSUE WAS FOUND BEFORE PATIENT ENTERED THE ROOM. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SPECIMEN CONTAINER SUPPLIER MEDEGEN MEDICAL PRODUCTS LLC. THE SAMPLE HAS NOT BEEN RETURNED TO DEROYAL FOR EVALUATION AT THIS TIME. THIS INVESTIGATION IS ONGOING AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SPECIMEN CONTAINER SUPPLIER MEDEGEN MEDICAL PRODUCTS LLC. THE SPECIMEN CONTAINER WAS RETURNED TO DEROYAL FOR EVALUATION. THE ROOT CAUSE IS UNKNOWN OR INCONCLUSIVE AS THE CONTAMINANT COULD NOT BE IDENTIFIED BY MEDEGEN MEDICAL PRODUCTS. MEDEGEN MEDICAL PRODUCTS DETERMINED A POTENTIAL CAUSE OF THE CONTAMINANT DISLODGED FROM AN UNDETERMINED LOCATION AND ENTERED THE EDGE OF THE LID DURING THE MANUFACTURING PROCESS. NO CORRECTIVE ACTIONS HAVE TAKEN PLACE BY MEDEGEN MEDICAL PRODUCTS DUE TO THE ROOT CAUSE OF THE CONTAMINANT IS UNKNOWN AND INCONCLUSIVE. AN INVENTORY CHECK OF THE SPECIMEN CONTAINER WAS MADE BY DEROYAL, A TOTAL OF 32 OF THE 979124 SPECIMEN CONTAINER WAS INSPECTED, AND NO DISCREPANCIES WERE IDENTIFIED DURING THE INSPECTION. 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

    CONTAMINANT INSIDE LID OF SPECIMEN CONTAINER. FOUND BEFORE PATIENT ENTERED THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654832 CMC EXTREMITY PACK GENERAL SURGERY TRAY (KIT) LRO DEROYAL INDUSTRIES, INC. 89-10552 55723370 00749756363549

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown